Director, Clinical Research Clinician, MD ROLE SUMMARY Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region). Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document. ROLE SUMMARY The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and provide assistance to new business development on market opportunities and the target product profile. ROLE RESPONSIBILITIES In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required. ROLE RESPONSIBILITIES Accountable for safety across the study: Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the "Safety Data Review Guide - for Clinicians." Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessments. Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study. Communicates safety information to sites across the study and provides responses to questions on safety. Protocol design and strategy: Provide medical input during development and updates to the clinical development plan. Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy. Ensure that documents (protocol, Informed Consent Document ICD , etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs. Provides medical input into country feasibility. Support study team Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team). Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied. Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing. Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting. Ensures the medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, or ). Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites (leveraging the RMMs when assigned) during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Interacts with DMCs and steering committees as required. Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events. Monitor investigator compliance with protocol and regulatory requirements. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Supports the program team: Authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report). May co-author abstracts, posters, presentations and publications. May contribute budget execution of protocols Interact with regulatory authorities, key opinion leaders, and principal investigators: Supports Clinical Regulatory Authority interactions accountable for providing responses. Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials QUALIFICATIONS Indicate basic and preferred qualifications: Basic Qualifications are job related, consistent with business requirements and necessary for the performance of an essential function of this role including: education/licenses/certifications, location, relevant experience, technical and/or other job-related skills. Basic qualifications determine minimum requirements that applicants must possess to be qualified for the role; anyone who does not meet basic qualifications for the role will not be interviewed or eligible for hire. Preferred Qualifications are job-related qualifications that may be indicated in addition to basic qualifications; they are not absolutely required for performance of the job but are desired and further describe the education/skills/experience sought for the position. Preferred qualifications enhance a candidate's ability to perform the job. BASIC QUALIFICATIONS Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year), and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year. Possesses the ability to critically evaluate medical/scientific information. Excellent written an oral communication. Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast pace and changing environment. Documented experience in the pharmaceutical industry related to clinical research programs and registration activities. Responsible for managing multiple studies PREFERRED QUALIFICATIONS Medical degree (M.D./D.O. or equivalent). Documented work experience/knowledge of statistics. Training and experience in infectious diseases and/or infection control in the hospital setting is preferred. Experience with investigational clinical trials is preferred Work Location Assignment: On Premise (Marlow, UK)
Apr 19, 2024
Full time
Director, Clinical Research Clinician, MD ROLE SUMMARY Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region). Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document. ROLE SUMMARY The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and provide assistance to new business development on market opportunities and the target product profile. ROLE RESPONSIBILITIES In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required. ROLE RESPONSIBILITIES Accountable for safety across the study: Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the "Safety Data Review Guide - for Clinicians." Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessments. Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study. Communicates safety information to sites across the study and provides responses to questions on safety. Protocol design and strategy: Provide medical input during development and updates to the clinical development plan. Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy. Ensure that documents (protocol, Informed Consent Document ICD , etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs. Provides medical input into country feasibility. Support study team Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team). Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied. Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing. Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting. Ensures the medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, or ). Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites (leveraging the RMMs when assigned) during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Interacts with DMCs and steering committees as required. Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events. Monitor investigator compliance with protocol and regulatory requirements. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Supports the program team: Authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report). May co-author abstracts, posters, presentations and publications. May contribute budget execution of protocols Interact with regulatory authorities, key opinion leaders, and principal investigators: Supports Clinical Regulatory Authority interactions accountable for providing responses. Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials QUALIFICATIONS Indicate basic and preferred qualifications: Basic Qualifications are job related, consistent with business requirements and necessary for the performance of an essential function of this role including: education/licenses/certifications, location, relevant experience, technical and/or other job-related skills. Basic qualifications determine minimum requirements that applicants must possess to be qualified for the role; anyone who does not meet basic qualifications for the role will not be interviewed or eligible for hire. Preferred Qualifications are job-related qualifications that may be indicated in addition to basic qualifications; they are not absolutely required for performance of the job but are desired and further describe the education/skills/experience sought for the position. Preferred qualifications enhance a candidate's ability to perform the job. BASIC QUALIFICATIONS Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year), and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year. Possesses the ability to critically evaluate medical/scientific information. Excellent written an oral communication. Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast pace and changing environment. Documented experience in the pharmaceutical industry related to clinical research programs and registration activities. Responsible for managing multiple studies PREFERRED QUALIFICATIONS Medical degree (M.D./D.O. or equivalent). Documented work experience/knowledge of statistics. Training and experience in infectious diseases and/or infection control in the hospital setting is preferred. Experience with investigational clinical trials is preferred Work Location Assignment: On Premise (Marlow, UK)
CSL Vifor is a world leading pharmaceutical company focused on Nephrology, Iron Deficiency and Cardio-Renal therapies. At this time we are seeking to add to our medical affairs leadership in the UK with a Head of Field Medical Affairs UK. In this position reporting to the UK Medical Director, you will manage a high performing team of Field Based Medical Advisors across the whole of the UK covering the entire CSL Vifor portfolio which includes assets earmarked for launch in 2024 and beyond. Critical to success in this role is the ability to act already as a qualified ABPI final signatory and to have previously managed teams within medical affairs. You will provide support and leadership utilizing your knowledge of the UK HCP landscape to drive medical performance and collaborate with local brand and commercial teams. Key Measures of Success Strong leadership ensuring high performing field based medical team Strong compliance culture and timely ABPI review and certifications for CSL Vifor therapy areas Demonstrated knowledge and expertise in TAs and products through KOL engagement, presentations, education and training Strong relationships with KOLs, enhancing scientific engagement & insights and strong medical collaboration Quantitative and Qualitative metrics demonstrated and measured, defined by Global Medical Affairs in alignment with Country Head of Medical Demonstrated support for clinical trial and Investigator Initiated Study (IIS) process support Demonstrated and aligned collaboration with cross-functional stakeholder to meet corporate goals Main Accountabilities Leadership, coaching and management of field medical affairs team across CSL Vifor therapy areas Alignment of knowledge, skills and behaviors of field medical advisors Setting and measuring performance of field medical teams in terms of value they can add Represent Medical Affairs externally to establish and maintain medical relationships with Key Opinion Leaders (KOLs), HCPs and key accounts on behalf of CSL Vifor Execute country medical plans locally by representing the medical expertise in TAs and products and through scientific engagement with the medical community Act as final signatory for all medical and commercial activities as per the ABPI code of practice Provide disease state education, medical information and research support Share scientific insights from medical community interactions with local & global medical teams, ensuring capturing of field medical expertise Train colleagues internally, all in accordance with global and local compliance and regulations Minimum Requirements GMC registered medical doctor or Registered pharmacist (e.g. Medicine, Pharmacy, Biology/ Biochemistry) Final signatory as per ABPI rules Demonstrated experience in KOL, HCP or medical community engagement Excellent oral and written communication skills; experience with digital communication Experience in public scientific presentations Ability for overnight travel, up to 30% Preferred Qualification Medical Education (MD) with relevant clinical experience Clinical and/or research experience in Nephrology, cardiology or transplant 5 years' experience with pharma industry locally, regionally or globally 3 years' experience in Medical affairs Management within pharmaceutical industry Strong track record in KOL engagement Experience in clinical research Experience in literature review and analysis Experience in planning and delivering Medical Trainings About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
Apr 19, 2024
Full time
CSL Vifor is a world leading pharmaceutical company focused on Nephrology, Iron Deficiency and Cardio-Renal therapies. At this time we are seeking to add to our medical affairs leadership in the UK with a Head of Field Medical Affairs UK. In this position reporting to the UK Medical Director, you will manage a high performing team of Field Based Medical Advisors across the whole of the UK covering the entire CSL Vifor portfolio which includes assets earmarked for launch in 2024 and beyond. Critical to success in this role is the ability to act already as a qualified ABPI final signatory and to have previously managed teams within medical affairs. You will provide support and leadership utilizing your knowledge of the UK HCP landscape to drive medical performance and collaborate with local brand and commercial teams. Key Measures of Success Strong leadership ensuring high performing field based medical team Strong compliance culture and timely ABPI review and certifications for CSL Vifor therapy areas Demonstrated knowledge and expertise in TAs and products through KOL engagement, presentations, education and training Strong relationships with KOLs, enhancing scientific engagement & insights and strong medical collaboration Quantitative and Qualitative metrics demonstrated and measured, defined by Global Medical Affairs in alignment with Country Head of Medical Demonstrated support for clinical trial and Investigator Initiated Study (IIS) process support Demonstrated and aligned collaboration with cross-functional stakeholder to meet corporate goals Main Accountabilities Leadership, coaching and management of field medical affairs team across CSL Vifor therapy areas Alignment of knowledge, skills and behaviors of field medical advisors Setting and measuring performance of field medical teams in terms of value they can add Represent Medical Affairs externally to establish and maintain medical relationships with Key Opinion Leaders (KOLs), HCPs and key accounts on behalf of CSL Vifor Execute country medical plans locally by representing the medical expertise in TAs and products and through scientific engagement with the medical community Act as final signatory for all medical and commercial activities as per the ABPI code of practice Provide disease state education, medical information and research support Share scientific insights from medical community interactions with local & global medical teams, ensuring capturing of field medical expertise Train colleagues internally, all in accordance with global and local compliance and regulations Minimum Requirements GMC registered medical doctor or Registered pharmacist (e.g. Medicine, Pharmacy, Biology/ Biochemistry) Final signatory as per ABPI rules Demonstrated experience in KOL, HCP or medical community engagement Excellent oral and written communication skills; experience with digital communication Experience in public scientific presentations Ability for overnight travel, up to 30% Preferred Qualification Medical Education (MD) with relevant clinical experience Clinical and/or research experience in Nephrology, cardiology or transplant 5 years' experience with pharma industry locally, regionally or globally 3 years' experience in Medical affairs Management within pharmaceutical industry Strong track record in KOL engagement Experience in clinical research Experience in literature review and analysis Experience in planning and delivering Medical Trainings About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
Machine Learning Engineer Analytics Centre of Excellence (ACOE) London/Hybrid The Analytics Centre of Excellence (ACOE) is positively impacting patient lives through the anticipation and delivery of Decision Intelligence solutions that increase clinical trial success, shorten drug development timelines, and reduce costs in bringing new drugs to market, getting much-needed drugs to patients faster through successful clinical trial delivery. Our vision at the ACOE is that every decision our users and clients make in R&D is made through Decision Intelligence, allowing speedy access to safe, novel, and effective treatments for all patients. ACOE Product Portfolio: In trial strategy, we are using Machine Learning (ML) to recommend countries and clinical trial sites and accurately predict clinical study timelines. We are deploying ML at clinical trial sites to read Electronic Medical Records data and find undiagnosed patients that are otherwise challenging to identify. We are optimizing our patient outreach targeting and are predicting participant dropout. In addition, problems in patient recruitment are being solved with ML. Further upstream in R&D we are predicting clinical trial outcomes, drug-protein interactions, repurposing drugs and even leveraging ML to optimize molecules. Job Overview Develop fit for purpose AIML models/algorithms/processes to address pharma/healthcare applications and innovative products upon completion of prototypes followed by the building of production grade algorithms/automation engines for client deliverables. Test for viability to deliver final products to clients. Able to bring newly researched ideas to reality quickly and on a large scale. Design, build, test, and deliver products from post-prototype to client delivery. Essential Functions Facilitates the transformation of machine learning research domain expertise in the areas of human data into viable prototypes Facilitates the development of features of models on individual projects and/or products with guidance and support from others Develops understanding of the creation of new algorithms through working alongside other Machine Learning Engineers and Machine Learning Research Scientists Facilitates the building and training of new production grade algorithms that can learn from complex, high dimensionality data to uncover patterns from which machine learning models and applications can be developed Uses a variety of techniques to improve the performance of individual natural language processing and/or machine learning algorithms Facilitates the testing and validation of models to determine viability for deployment with guidance and support from others Consult for internal and external clients, implement solution development and innovation to meet clients' needs, facilitate client AI project technical delivery What we're looking for Master's Degree Master's Degree in Machine Learning, Statistics, Computer Science, Physics, Math, or related field Several years' experience working on creating machine learning algorithms Programming experience using one or more of the following: Python, Java, C++, R, Go, Kubernetes, Deep learning or equivalent. Python (Scikit-learn, Tensor Flow, Pandas, NumPy, SciPy) SQL, Linux/mac command-line tools Experience with building, testing, measuring, and deploying machine learning models in production Familiarity with ML algorithms (classification, regression) and processes (how to build models, assess their goodness of fit, etc.) Familiarity with agile software development lifecycle (SCRUM, Kanban, etc.) Previous experience of owning, maintaining, and enhancing software data products Attention to clarity of code, ease of development, and correctness of implementations Good knowledge of software development best practices including testing, continuous integration, and DevOps tools Preferred Requirements: Knowledge and experience of Hierarchical Modelling Experience with clinical domain and with regulated data Used Deep Neural Network libraries such as Tensor Flow, especially with Bayesian Neural Networks Knowledge of cloud systems such as AWS, Azure, GCP and containerization such as Docker Experience working with large, real-world datasets Demonstrated in-depth understanding of product development lifecycle Demonstrated aptitude for and interest in peer mentorship Experience deploying code into production through CI/CD tools Knowledge of biostatistics/life sciences/healthcare technology Knowledge of UX principles Experience working in the Hadoop ecosystem Why Join? Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care. You will have access to the most cutting-edge technology, the largest data sets, the best analytics tools and, in our opinion, some of the finest minds in the Healthcare industry. You can drive your career at IQVIA and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. It's an exciting time to join and reimagine what's possible in healthcare. IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential. We thank all applicants for their interest; however only those selected for interview will be contacted. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
Apr 18, 2024
Full time
Machine Learning Engineer Analytics Centre of Excellence (ACOE) London/Hybrid The Analytics Centre of Excellence (ACOE) is positively impacting patient lives through the anticipation and delivery of Decision Intelligence solutions that increase clinical trial success, shorten drug development timelines, and reduce costs in bringing new drugs to market, getting much-needed drugs to patients faster through successful clinical trial delivery. Our vision at the ACOE is that every decision our users and clients make in R&D is made through Decision Intelligence, allowing speedy access to safe, novel, and effective treatments for all patients. ACOE Product Portfolio: In trial strategy, we are using Machine Learning (ML) to recommend countries and clinical trial sites and accurately predict clinical study timelines. We are deploying ML at clinical trial sites to read Electronic Medical Records data and find undiagnosed patients that are otherwise challenging to identify. We are optimizing our patient outreach targeting and are predicting participant dropout. In addition, problems in patient recruitment are being solved with ML. Further upstream in R&D we are predicting clinical trial outcomes, drug-protein interactions, repurposing drugs and even leveraging ML to optimize molecules. Job Overview Develop fit for purpose AIML models/algorithms/processes to address pharma/healthcare applications and innovative products upon completion of prototypes followed by the building of production grade algorithms/automation engines for client deliverables. Test for viability to deliver final products to clients. Able to bring newly researched ideas to reality quickly and on a large scale. Design, build, test, and deliver products from post-prototype to client delivery. Essential Functions Facilitates the transformation of machine learning research domain expertise in the areas of human data into viable prototypes Facilitates the development of features of models on individual projects and/or products with guidance and support from others Develops understanding of the creation of new algorithms through working alongside other Machine Learning Engineers and Machine Learning Research Scientists Facilitates the building and training of new production grade algorithms that can learn from complex, high dimensionality data to uncover patterns from which machine learning models and applications can be developed Uses a variety of techniques to improve the performance of individual natural language processing and/or machine learning algorithms Facilitates the testing and validation of models to determine viability for deployment with guidance and support from others Consult for internal and external clients, implement solution development and innovation to meet clients' needs, facilitate client AI project technical delivery What we're looking for Master's Degree Master's Degree in Machine Learning, Statistics, Computer Science, Physics, Math, or related field Several years' experience working on creating machine learning algorithms Programming experience using one or more of the following: Python, Java, C++, R, Go, Kubernetes, Deep learning or equivalent. Python (Scikit-learn, Tensor Flow, Pandas, NumPy, SciPy) SQL, Linux/mac command-line tools Experience with building, testing, measuring, and deploying machine learning models in production Familiarity with ML algorithms (classification, regression) and processes (how to build models, assess their goodness of fit, etc.) Familiarity with agile software development lifecycle (SCRUM, Kanban, etc.) Previous experience of owning, maintaining, and enhancing software data products Attention to clarity of code, ease of development, and correctness of implementations Good knowledge of software development best practices including testing, continuous integration, and DevOps tools Preferred Requirements: Knowledge and experience of Hierarchical Modelling Experience with clinical domain and with regulated data Used Deep Neural Network libraries such as Tensor Flow, especially with Bayesian Neural Networks Knowledge of cloud systems such as AWS, Azure, GCP and containerization such as Docker Experience working with large, real-world datasets Demonstrated in-depth understanding of product development lifecycle Demonstrated aptitude for and interest in peer mentorship Experience deploying code into production through CI/CD tools Knowledge of biostatistics/life sciences/healthcare technology Knowledge of UX principles Experience working in the Hadoop ecosystem Why Join? Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care. You will have access to the most cutting-edge technology, the largest data sets, the best analytics tools and, in our opinion, some of the finest minds in the Healthcare industry. You can drive your career at IQVIA and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. It's an exciting time to join and reimagine what's possible in healthcare. IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential. We thank all applicants for their interest; however only those selected for interview will be contacted. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
ROLE SUMMARY The clinician medical monitor should be able to function independently and have direct experience with all the steps in designing and delivering results of clinical trials by applying extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical projects. The clinician medical monitor ensures successful global program implementation through oversight and review of the global program design including the clinical development plan or lifecycle strategy. The clinician medical monitor partners with Franchise Lead in identifying and advancing new concepts and processes to provide innovative strategies to solve clinical issues. By directing and obtaining consensus from senior staff members, the clinician medical monitor solves highly complex and specialised problems related to clinical research programs. The clinician medical monitor applies technical/scientific expertise to resolve problems regarding the clinical components of documents (e.g., Investigational New Drugs, New Drug Applications/Common Technical Documents, global registration dossiers, lifecycle strategy documents, internal documents). The clinician medical monitor provides procedural and scientific subject matter expertise to steer clinician medical monitors, clinician clinical scientists, clinical scientist leads, and other clinical staff members. The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for clinical trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. In addition to study level activities, the clinician medical monitor will participate in standing committees, review opportunities for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a vaccine or group of vaccines. Mentor and/or manage more junior medical monitor colleagues. ROLE RESPONSIBILITIES Accountable for participant safety Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Accountable for the development of and adherence to the Safety Surveillance Review Plan (SSRP) for a vaccine development program Has oversight of the subject safety data for all studies within a program, and the review of cumulative safety data with the safety risk lead. Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Steers discussion on benefit-risk analysis across functions Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study. Communicates safety information to sites across the study and provides responses to questions on safety. Protocol design and strategy Responsible for development of the Clinical Development Plan. Designs clinical studies to meet the stated objectives of a program. Assures that clinical trial objectives of each study fit with the clinical program strategy. Ensure that documents (protocol, Informed Consent Document ICD , etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs Provides medical input into country feasibility. Support study team Has oversight of clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team) Contributes to contract research organisation / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied. Works with study team to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing. Ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting are conducted appropriately. Ensures the medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, or ) Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites (leveraging Site Care Partners when assigned) during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Interacts with DMCs and steering committees as required. Is responsible for ensuring all materials are provided to DMC. Coordinates medical opinions with other colleagues globally to ensure consistency at program level. Ensures that appropriate study team colleagues are notified to inform investigators of any changes in research activity and any significant new adverse events. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Support program team Ensures that the clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report) are completed timely. May co-author abstracts, posters, presentations and publications Acts as clinical representative in in-licensing activities such as due diligence reviews and reports. May be a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Global Product Development and other members of the extended project team(s) Responsible for the on-time and within-budget execution of protocols Interact with regulatory authorities, key opinion leaders, and principal investigators. Leads Clinical Regulatory Authority interactions, accountable for providing responses. Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials. BASIC QUALIFICATIONS Medical degree (M.D./D.O. or equivalent) Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilised the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year. Possesses the ability to critically evaluate medical/scientific information. Propose new concepts and innovative ideas in drug development. Excellent written and oral communication Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast paced and changing environment. Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PREFERRED QUALIFICATIONS Training and experience in infectious diseases and/or infection control in the hospital setting is preferred. Documented work experience/knowledge of statistics Experience with investigational clinical trials is preferred. Documented experience in the pharmaceutical industry related to clinical research programs and registration activities. Work Location Assignment: On Premise (Marlow, UK)
Apr 18, 2024
Full time
ROLE SUMMARY The clinician medical monitor should be able to function independently and have direct experience with all the steps in designing and delivering results of clinical trials by applying extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical projects. The clinician medical monitor ensures successful global program implementation through oversight and review of the global program design including the clinical development plan or lifecycle strategy. The clinician medical monitor partners with Franchise Lead in identifying and advancing new concepts and processes to provide innovative strategies to solve clinical issues. By directing and obtaining consensus from senior staff members, the clinician medical monitor solves highly complex and specialised problems related to clinical research programs. The clinician medical monitor applies technical/scientific expertise to resolve problems regarding the clinical components of documents (e.g., Investigational New Drugs, New Drug Applications/Common Technical Documents, global registration dossiers, lifecycle strategy documents, internal documents). The clinician medical monitor provides procedural and scientific subject matter expertise to steer clinician medical monitors, clinician clinical scientists, clinical scientist leads, and other clinical staff members. The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for clinical trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. In addition to study level activities, the clinician medical monitor will participate in standing committees, review opportunities for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a vaccine or group of vaccines. Mentor and/or manage more junior medical monitor colleagues. ROLE RESPONSIBILITIES Accountable for participant safety Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Accountable for the development of and adherence to the Safety Surveillance Review Plan (SSRP) for a vaccine development program Has oversight of the subject safety data for all studies within a program, and the review of cumulative safety data with the safety risk lead. Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Steers discussion on benefit-risk analysis across functions Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study. Communicates safety information to sites across the study and provides responses to questions on safety. Protocol design and strategy Responsible for development of the Clinical Development Plan. Designs clinical studies to meet the stated objectives of a program. Assures that clinical trial objectives of each study fit with the clinical program strategy. Ensure that documents (protocol, Informed Consent Document ICD , etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs Provides medical input into country feasibility. Support study team Has oversight of clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team) Contributes to contract research organisation / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied. Works with study team to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing. Ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting are conducted appropriately. Ensures the medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, or ) Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites (leveraging Site Care Partners when assigned) during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Interacts with DMCs and steering committees as required. Is responsible for ensuring all materials are provided to DMC. Coordinates medical opinions with other colleagues globally to ensure consistency at program level. Ensures that appropriate study team colleagues are notified to inform investigators of any changes in research activity and any significant new adverse events. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Support program team Ensures that the clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report) are completed timely. May co-author abstracts, posters, presentations and publications Acts as clinical representative in in-licensing activities such as due diligence reviews and reports. May be a key member of the Program team, interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory, outcomes research, Global Product Development and other members of the extended project team(s) Responsible for the on-time and within-budget execution of protocols Interact with regulatory authorities, key opinion leaders, and principal investigators. Leads Clinical Regulatory Authority interactions, accountable for providing responses. Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials. BASIC QUALIFICATIONS Medical degree (M.D./D.O. or equivalent) Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilised the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year. Possesses the ability to critically evaluate medical/scientific information. Propose new concepts and innovative ideas in drug development. Excellent written and oral communication Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast paced and changing environment. Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PREFERRED QUALIFICATIONS Training and experience in infectious diseases and/or infection control in the hospital setting is preferred. Documented work experience/knowledge of statistics Experience with investigational clinical trials is preferred. Documented experience in the pharmaceutical industry related to clinical research programs and registration activities. Work Location Assignment: On Premise (Marlow, UK)
PRA International is one of the world's leading Global Clinical Research Organisations. With an established presence, spanning more that 30 years, they have enjoyed continual growth and success, currently employing 3,200 staff globally. PRA have managed to continually build and enhance their reputation through delivering a service that is reliable, with a high level of therapeutic expertise and global access to knowledge. This is enhanced by having a wealth of CRO, clinical and product development expertise within their senior management, all of whom work closely alongside their customers. PRA International - History Established in the late 1970's with name changed to Pharmaceutical Research Associates Inc., in 1981 with focus on data management in Virginia, USA. In 1991, PRA expanded its service offering to include clinical trial management and opened their first European location. 1996 saw the company name change to PRA International as the company moved towards becoming a global CRO with 333 employees. In 1997, PRA acquired International Medical and Technical Consultants (IMTCI), a CRO based in Lenexa, Kansas. This increased PRA International's clinical trials leadership, expertise and experience within the key therapeutic areas of allergy and respiratory. Additionally they gained a Phase I facility. In 1999, PRA acquired Valorum (UK) Ltd, based in Reading, UK. This acquisition enhanced their regulatory expertise and expanded PRA's trial management footprint in Europe. In 2000, PRA acquired ARCAM, an international CRO based in Paris, France. This further enhanced PRAs capability in Europe, across a number of therapeutic areas within clinical trial management, project management and quality assurance. This enhanced PRAs European footprint to in excess of 250 employees. In 2002, PRA acquired Staticon International Espana, an established CRO in Madrid, Spain, further developed their service offering in Europe and in particular bringing enhanced capability in electronic data capture and management. In 2002, PRA acquired CroMedica, a CRO headquartered in Canada with key expertise in the CNS therapeutic area and global operations. Several of their offices now represent PRA in Victoria, British Columbia; San Diego, California; Sao Paulo, Brazil; Johannesburg and Cape Town, South Africa; and Sydney, Australia. In November 2004, PRA became a publicly traded company on the NASDAQ exchange. In June 2006, PRA acquired Pharma Bio-Research, an early phase clinical development and bioanalytical laboratory company based in The Netherlands, forming the basis for the group within PRA now known as Early Development Services. In October 2007, PRA acquired Pharmacon, a clinical research organisation based in Berlin, Germany. Specialising in Phase I studies with patients in several Central European countries, this was an important step in PRA's Early Development Services plan to further strengthen its position as an industry leader. PRA returned to being a privately held company when it was reacquired by Genstar Capital, LLC in December 2007. Genstar had been PRA's largest investor before the initial public offering in 2004. PRA International's mission: 'Our people commit to provide innovative solutions that our clients rely upon to introduce new drugs and to improve lives' PRA International - Core Values Unquestionable ethics and integrity Consistent and measurable quality in all they do Outstanding service and flexibility to meet customer requirements Commitment to staff development and collaboration Demonstrated technical and therapeutic excellence throughout the company PRA International - Key Services Protocol and Case Report Form design Feasibility study Project Management Investigator site selection and qualification Investigator handbook and meetings Medical monitoring and drug safety Data management Analysis and reporting Medical and scientific publications Regulatory filings Early Development Services Single and multiple dose safety and tolerability studies Food effect Proof of concept studies Interaction studies with drugs and food Mass balance / ADME studies Single and multiple dose bioavailability studies QTc - prolongation and intensive ECG studies PK studies in renally impaired patients PK studies in hepatically impaired patients Special formulations Studies with biotechnology-derived therapeutic products Late Phase Services Post-authorisation safety studies (PASS) Restricted access programs Drug Safety Management Reporting of serious adverse events Processing and reporting of adverse drug reactions (ADRs) Periodic safety update reports Safety and Pharmaco-Epidemiological Studies Global database pooling and integrated summaries of safety Consulting and system analysis Electronic Regulatory Submissions Protocol and Case Report Form design Feasibility study Project Management Investigator site selection and qualification For further information, please go to Context of the role Approximately two years ago, the decision was taken to create a new role within the global operations function focused on the development and management of PRA's key customers and oversight of international trials and programmes. The thinking behind this strategy was to provide a dedicated resource to strategic clients at a global level thereby ensuring PRA could develop a deep knowledge of the client, their portfolio, pipeline, culture and vision. Additionally, the client could benefit from a single point of contact for their operational and commercial needs. In executing this strategy, PRA set out to build a team of Project Delivery professionals who would work alongside operational and commercial groups to coordinate activities relating to specific accounts. Over the last 18 months, PRA have targeted experienced global study management and clinical operations professionals, both internally and externally, who have sought to leverage their clinical research knowledge and experience in a client facing role. Today, the Project Delivery team is 13 strong and is led by six General Partners worldwide. Their remit is to provide client management, leadership and project mentorship with the goal of providing outstanding customer delivery and developing a strong, long-term relationship with the customer. In the last few months, PRA have been awarded preferred provider status with a global pharmaceutical company and the need has arisen to recruit an additional Director, Project Delivery to the team. Reporting to the UK based General Partner, the role can be based at one of PRA's European offices or may be home based for the right candidate. PRA are seeking a professional with a life sciences degree who brings extensive experience in global phase I-IV clinical trial management and strong commercial skills. You will already be liaising with clinical research and procurement professionals at a senior level within the pharmaceutical industry and comfortable with managing a portfolio of multi-centre international studies. This is a unique opportunity to join a dynamic and growing business unit within one of the leading global CROs in a role which offers tremendous scope for career development and enhancement. Job Description Primary Purpose of the Role Accountable for maintaining relationships (i.e. maintaining repeat business) with assigned Customer(s)/projects through excellence of project delivery of awarded projects whilst maintaining bid profitability. Accountabilities Frequent and routine (e.g. weekly) face-to-face and remote liaison with Customer contacts to review and discuss status (e.g. project successes, issues, opportunities) of awarded projects. Networking within Customer to extend contacts and develop business opportunities for PRA. Leads Project Status Reviews (PSRs) for assigned projects including risk assessment. Ensures maintenance of bid profitability through thorough review of projections of revenue, estimates of cost to complete and timely execution of contract modifications for awarded projects. Create action plans to minimize inefficiencies when recovery from the customer is not possible. First point of escalation (internal and external) for resolution of issues and conflicts (e.g. escalation from PSRs). Member of Executive Oversight/Operations Committees for assigned Customers as requested. Ownership of strategy development for proposals. Owner of content of materials to be used at bid defense meetings. Logistics of bid defense meeting (slide preparation, attendance requests and preparation meeting) will be responsibility of the Sales personnel provided by Business Development. Mentor Project Managers (all levels) leading assigned projects and provides feedback on performance to line-managers of Project Managers (Director of Project Managers). Education An undergraduate degree in health sciences from an accredited institution or international equivalent degree. An advanced degree (M.S., Ph.D., Pharm.D., M.D.) preferred Business related coursework (management, marketing, accounting, budgets, personnel management, negotiation skills, etc.) preferred . click apply for full job details
Apr 18, 2024
Full time
PRA International is one of the world's leading Global Clinical Research Organisations. With an established presence, spanning more that 30 years, they have enjoyed continual growth and success, currently employing 3,200 staff globally. PRA have managed to continually build and enhance their reputation through delivering a service that is reliable, with a high level of therapeutic expertise and global access to knowledge. This is enhanced by having a wealth of CRO, clinical and product development expertise within their senior management, all of whom work closely alongside their customers. PRA International - History Established in the late 1970's with name changed to Pharmaceutical Research Associates Inc., in 1981 with focus on data management in Virginia, USA. In 1991, PRA expanded its service offering to include clinical trial management and opened their first European location. 1996 saw the company name change to PRA International as the company moved towards becoming a global CRO with 333 employees. In 1997, PRA acquired International Medical and Technical Consultants (IMTCI), a CRO based in Lenexa, Kansas. This increased PRA International's clinical trials leadership, expertise and experience within the key therapeutic areas of allergy and respiratory. Additionally they gained a Phase I facility. In 1999, PRA acquired Valorum (UK) Ltd, based in Reading, UK. This acquisition enhanced their regulatory expertise and expanded PRA's trial management footprint in Europe. In 2000, PRA acquired ARCAM, an international CRO based in Paris, France. This further enhanced PRAs capability in Europe, across a number of therapeutic areas within clinical trial management, project management and quality assurance. This enhanced PRAs European footprint to in excess of 250 employees. In 2002, PRA acquired Staticon International Espana, an established CRO in Madrid, Spain, further developed their service offering in Europe and in particular bringing enhanced capability in electronic data capture and management. In 2002, PRA acquired CroMedica, a CRO headquartered in Canada with key expertise in the CNS therapeutic area and global operations. Several of their offices now represent PRA in Victoria, British Columbia; San Diego, California; Sao Paulo, Brazil; Johannesburg and Cape Town, South Africa; and Sydney, Australia. In November 2004, PRA became a publicly traded company on the NASDAQ exchange. In June 2006, PRA acquired Pharma Bio-Research, an early phase clinical development and bioanalytical laboratory company based in The Netherlands, forming the basis for the group within PRA now known as Early Development Services. In October 2007, PRA acquired Pharmacon, a clinical research organisation based in Berlin, Germany. Specialising in Phase I studies with patients in several Central European countries, this was an important step in PRA's Early Development Services plan to further strengthen its position as an industry leader. PRA returned to being a privately held company when it was reacquired by Genstar Capital, LLC in December 2007. Genstar had been PRA's largest investor before the initial public offering in 2004. PRA International's mission: 'Our people commit to provide innovative solutions that our clients rely upon to introduce new drugs and to improve lives' PRA International - Core Values Unquestionable ethics and integrity Consistent and measurable quality in all they do Outstanding service and flexibility to meet customer requirements Commitment to staff development and collaboration Demonstrated technical and therapeutic excellence throughout the company PRA International - Key Services Protocol and Case Report Form design Feasibility study Project Management Investigator site selection and qualification Investigator handbook and meetings Medical monitoring and drug safety Data management Analysis and reporting Medical and scientific publications Regulatory filings Early Development Services Single and multiple dose safety and tolerability studies Food effect Proof of concept studies Interaction studies with drugs and food Mass balance / ADME studies Single and multiple dose bioavailability studies QTc - prolongation and intensive ECG studies PK studies in renally impaired patients PK studies in hepatically impaired patients Special formulations Studies with biotechnology-derived therapeutic products Late Phase Services Post-authorisation safety studies (PASS) Restricted access programs Drug Safety Management Reporting of serious adverse events Processing and reporting of adverse drug reactions (ADRs) Periodic safety update reports Safety and Pharmaco-Epidemiological Studies Global database pooling and integrated summaries of safety Consulting and system analysis Electronic Regulatory Submissions Protocol and Case Report Form design Feasibility study Project Management Investigator site selection and qualification For further information, please go to Context of the role Approximately two years ago, the decision was taken to create a new role within the global operations function focused on the development and management of PRA's key customers and oversight of international trials and programmes. The thinking behind this strategy was to provide a dedicated resource to strategic clients at a global level thereby ensuring PRA could develop a deep knowledge of the client, their portfolio, pipeline, culture and vision. Additionally, the client could benefit from a single point of contact for their operational and commercial needs. In executing this strategy, PRA set out to build a team of Project Delivery professionals who would work alongside operational and commercial groups to coordinate activities relating to specific accounts. Over the last 18 months, PRA have targeted experienced global study management and clinical operations professionals, both internally and externally, who have sought to leverage their clinical research knowledge and experience in a client facing role. Today, the Project Delivery team is 13 strong and is led by six General Partners worldwide. Their remit is to provide client management, leadership and project mentorship with the goal of providing outstanding customer delivery and developing a strong, long-term relationship with the customer. In the last few months, PRA have been awarded preferred provider status with a global pharmaceutical company and the need has arisen to recruit an additional Director, Project Delivery to the team. Reporting to the UK based General Partner, the role can be based at one of PRA's European offices or may be home based for the right candidate. PRA are seeking a professional with a life sciences degree who brings extensive experience in global phase I-IV clinical trial management and strong commercial skills. You will already be liaising with clinical research and procurement professionals at a senior level within the pharmaceutical industry and comfortable with managing a portfolio of multi-centre international studies. This is a unique opportunity to join a dynamic and growing business unit within one of the leading global CROs in a role which offers tremendous scope for career development and enhancement. Job Description Primary Purpose of the Role Accountable for maintaining relationships (i.e. maintaining repeat business) with assigned Customer(s)/projects through excellence of project delivery of awarded projects whilst maintaining bid profitability. Accountabilities Frequent and routine (e.g. weekly) face-to-face and remote liaison with Customer contacts to review and discuss status (e.g. project successes, issues, opportunities) of awarded projects. Networking within Customer to extend contacts and develop business opportunities for PRA. Leads Project Status Reviews (PSRs) for assigned projects including risk assessment. Ensures maintenance of bid profitability through thorough review of projections of revenue, estimates of cost to complete and timely execution of contract modifications for awarded projects. Create action plans to minimize inefficiencies when recovery from the customer is not possible. First point of escalation (internal and external) for resolution of issues and conflicts (e.g. escalation from PSRs). Member of Executive Oversight/Operations Committees for assigned Customers as requested. Ownership of strategy development for proposals. Owner of content of materials to be used at bid defense meetings. Logistics of bid defense meeting (slide preparation, attendance requests and preparation meeting) will be responsibility of the Sales personnel provided by Business Development. Mentor Project Managers (all levels) leading assigned projects and provides feedback on performance to line-managers of Project Managers (Director of Project Managers). Education An undergraduate degree in health sciences from an accredited institution or international equivalent degree. An advanced degree (M.S., Ph.D., Pharm.D., M.D.) preferred Business related coursework (management, marketing, accounting, budgets, personnel management, negotiation skills, etc.) preferred . click apply for full job details
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. As our organisation continues to grow we are looking for aVice President, Regulatory Affairs who will provide worldwide, strategic leadership in and comprehensive understanding of the government regulatory requirements for product development utilizing regulatory knowledge and expertise to ensure regulatory compliance. Essential functions of the job include but are not limited to : Regulatory Oversight / Intelligence Develop and implement strategies for the timely preparation and execution of regulatory documents to regulatory authorities for contracted programs. Provide expert analysis and evaluation of regulatory information. Informs the teams (internal and external stakeholders, as needed) of the regulatory status of products / programs and significant regulatory issues. Provides analysis of regulatory guidance documents, regulations or directives that influence Precision's operations and impacted programs. Advises other departments as well as external stakeholders regarding their applicability and impact. Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures. Develop global regulatory strategy(s) for contracted clinical programs to ensure successful initiation, execution and submission for global registration. Lead and/or facilitate team preparation for regulatory agencies/Health Authority meetings. Lead and/or facilitate communications with regulatory agencies. Preparation of briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports Provide oversight to study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications. Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports) Lead and facilitate development of any USPI/SmPC labeling activities with cross functional teams for planned regulatory submission. Department Oversight / Leadership Provide guidance and leadership to the members of the Regulatory Affairs department. Develop, define and lead internal growth and resourcing strategy for Regulatory Affairs within the organization and direct and oversee all regulatory staff. Oversee the development and management of the regulatory infrastructure. Develop and manage a global budget and resourcing supporting Regulatory Affairs department. Hire, mentor, and support the personal and professional development of regulatory staff. Lead Regulatory Affairs business development activities. Contribute to development of regulatory consulting business to support client development and growth, to achieve an initial annual sales target for regulatory-specific work (outside of clinical trial support) Qualifications: Minimum Required: Bachelor's degree in life sciences or medicine 15+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience Mastery knowledge of all aspects of the drug development process inclusive of regulatory milestones Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development. Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines both strategically and operationally and provide direction to resolve complex regulatory issues. Prior experience in developing successful global development strategies of cutting edge and unique therapies. Expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA/BLA, Scientific Advice), NDAs/BLAs, and other major regulatory submission. Prior experience in business development activities Availability for domestic and international travel including overnight stays. Preferred: Advanced degree Experience growing and managing a global regulatory function - CRO and Pharma experience preferred. Prior work experience in haematology/oncology Ability to understand clinical and pre-clinical study results, to help in its interpretation for global regulatory positions and strategy. Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills. Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of business development and pharmaceutical collaborating are necessary. Proven ability to communicate with management, external thought-leaders and operational staff. Ability to guide, train and supervise personnel; oversees the work of direct reports to ensure ontime, on target and within budget results. Flexible attitude with respect to work assignments, and new learning opportunities We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
Apr 16, 2024
Full time
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. As our organisation continues to grow we are looking for aVice President, Regulatory Affairs who will provide worldwide, strategic leadership in and comprehensive understanding of the government regulatory requirements for product development utilizing regulatory knowledge and expertise to ensure regulatory compliance. Essential functions of the job include but are not limited to : Regulatory Oversight / Intelligence Develop and implement strategies for the timely preparation and execution of regulatory documents to regulatory authorities for contracted programs. Provide expert analysis and evaluation of regulatory information. Informs the teams (internal and external stakeholders, as needed) of the regulatory status of products / programs and significant regulatory issues. Provides analysis of regulatory guidance documents, regulations or directives that influence Precision's operations and impacted programs. Advises other departments as well as external stakeholders regarding their applicability and impact. Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures. Develop global regulatory strategy(s) for contracted clinical programs to ensure successful initiation, execution and submission for global registration. Lead and/or facilitate team preparation for regulatory agencies/Health Authority meetings. Lead and/or facilitate communications with regulatory agencies. Preparation of briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports Provide oversight to study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications. Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports) Lead and facilitate development of any USPI/SmPC labeling activities with cross functional teams for planned regulatory submission. Department Oversight / Leadership Provide guidance and leadership to the members of the Regulatory Affairs department. Develop, define and lead internal growth and resourcing strategy for Regulatory Affairs within the organization and direct and oversee all regulatory staff. Oversee the development and management of the regulatory infrastructure. Develop and manage a global budget and resourcing supporting Regulatory Affairs department. Hire, mentor, and support the personal and professional development of regulatory staff. Lead Regulatory Affairs business development activities. Contribute to development of regulatory consulting business to support client development and growth, to achieve an initial annual sales target for regulatory-specific work (outside of clinical trial support) Qualifications: Minimum Required: Bachelor's degree in life sciences or medicine 15+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience Mastery knowledge of all aspects of the drug development process inclusive of regulatory milestones Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development. Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines both strategically and operationally and provide direction to resolve complex regulatory issues. Prior experience in developing successful global development strategies of cutting edge and unique therapies. Expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA/BLA, Scientific Advice), NDAs/BLAs, and other major regulatory submission. Prior experience in business development activities Availability for domestic and international travel including overnight stays. Preferred: Advanced degree Experience growing and managing a global regulatory function - CRO and Pharma experience preferred. Prior work experience in haematology/oncology Ability to understand clinical and pre-clinical study results, to help in its interpretation for global regulatory positions and strategy. Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills. Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of business development and pharmaceutical collaborating are necessary. Proven ability to communicate with management, external thought-leaders and operational staff. Ability to guide, train and supervise personnel; oversees the work of direct reports to ensure ontime, on target and within budget results. Flexible attitude with respect to work assignments, and new learning opportunities We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. As our organisation continues to grow we are looking for a Senior Director / Executive Director / VP, Regulatory Affairs who will provide worldwide, strategic leadership in and comprehensive understanding of the government regulatory requirements for product development utilizing regulatory knowledge and expertise to ensure regulatory compliance. Essential functions of the job include but are not limited to : Regulatory Oversight / Intelligence Develop and implement strategies for the timely preparation and execution of regulatory documents to regulatory authorities for contracted programs. Provide expert analysis and evaluation of regulatory information. Informs the teams (internal and external stakeholders, as needed) of the regulatory status of products / programs and significant regulatory issues. Provides analysis of regulatory guidance documents, regulations or directives that influence Precision's operations and impacted programs. Advises other departments as well as external stakeholders regarding their applicability and impact. Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures. Develop global regulatory strategy(s) for contracted clinical programs to ensure successful initiation, execution and submission for global registration. Lead and/or facilitate team preparation for regulatory agencies/Health Authority meetings. Lead and/or facilitate communications with regulatory agencies. Preparation of briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports Provide oversight to study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications. Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports) Lead and facilitate development of any USPI/SmPC labeling activities with cross functional teams for planned regulatory submission. Department Oversight / Leadership Provide guidance and leadership to the members of the Regulatory Affairs department. Develop, define and lead internal growth and resourcing strategy for Regulatory Affairs within the organization and direct and oversee all regulatory staff. Oversee the development and management of the regulatory infrastructure. Develop and manage a global budget and resourcing supporting Regulatory Affairs department. Hire, mentor, and support the personal and professional development of regulatory staff. Lead Regulatory Affairs business development activities. Contribute to development of regulatory consulting business to support client development and growth, to achieve an initial annual sales target for regulatory-specific work (outside of clinical trial support) Qualifications: Minimum Required: Bachelor's degree in life sciences or medicine 15+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience Mastery knowledge of all aspects of the drug development process inclusive of regulatory milestones Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development. Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines both strategically and operationally and provide direction to resolve complex regulatory issues. Prior experience in developing successful global development strategies of cutting edge and unique therapies. Expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA/BLA, Scientific Advice), NDAs/BLAs, and other major regulatory submission. Prior experience in business development activities Availability for domestic and international travel including overnight stays. Preferred: Advanced degree Experience growing and managing a global regulatory function - CRO and Pharma experience preferred. Prior work experience in haematology/oncology Ability to understand clinical and pre-clinical study results, to help in its interpretation for global regulatory positions and strategy. Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills. Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of business development and pharmaceutical collaborating are necessary. Proven ability to communicate with management, external thought-leaders and operational staff. Ability to guide, train and supervise personnel; oversees the work of direct reports to ensure ontime, on target and within budget results. Flexible attitude with respect to work assignments, and new learning opportunities We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
Apr 16, 2024
Full time
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. As our organisation continues to grow we are looking for a Senior Director / Executive Director / VP, Regulatory Affairs who will provide worldwide, strategic leadership in and comprehensive understanding of the government regulatory requirements for product development utilizing regulatory knowledge and expertise to ensure regulatory compliance. Essential functions of the job include but are not limited to : Regulatory Oversight / Intelligence Develop and implement strategies for the timely preparation and execution of regulatory documents to regulatory authorities for contracted programs. Provide expert analysis and evaluation of regulatory information. Informs the teams (internal and external stakeholders, as needed) of the regulatory status of products / programs and significant regulatory issues. Provides analysis of regulatory guidance documents, regulations or directives that influence Precision's operations and impacted programs. Advises other departments as well as external stakeholders regarding their applicability and impact. Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures. Develop global regulatory strategy(s) for contracted clinical programs to ensure successful initiation, execution and submission for global registration. Lead and/or facilitate team preparation for regulatory agencies/Health Authority meetings. Lead and/or facilitate communications with regulatory agencies. Preparation of briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports Provide oversight to study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications. Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports) Lead and facilitate development of any USPI/SmPC labeling activities with cross functional teams for planned regulatory submission. Department Oversight / Leadership Provide guidance and leadership to the members of the Regulatory Affairs department. Develop, define and lead internal growth and resourcing strategy for Regulatory Affairs within the organization and direct and oversee all regulatory staff. Oversee the development and management of the regulatory infrastructure. Develop and manage a global budget and resourcing supporting Regulatory Affairs department. Hire, mentor, and support the personal and professional development of regulatory staff. Lead Regulatory Affairs business development activities. Contribute to development of regulatory consulting business to support client development and growth, to achieve an initial annual sales target for regulatory-specific work (outside of clinical trial support) Qualifications: Minimum Required: Bachelor's degree in life sciences or medicine 15+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience Mastery knowledge of all aspects of the drug development process inclusive of regulatory milestones Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development. Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines both strategically and operationally and provide direction to resolve complex regulatory issues. Prior experience in developing successful global development strategies of cutting edge and unique therapies. Expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA/BLA, Scientific Advice), NDAs/BLAs, and other major regulatory submission. Prior experience in business development activities Availability for domestic and international travel including overnight stays. Preferred: Advanced degree Experience growing and managing a global regulatory function - CRO and Pharma experience preferred. Prior work experience in haematology/oncology Ability to understand clinical and pre-clinical study results, to help in its interpretation for global regulatory positions and strategy. Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills. Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of business development and pharmaceutical collaborating are necessary. Proven ability to communicate with management, external thought-leaders and operational staff. Ability to guide, train and supervise personnel; oversees the work of direct reports to ensure ontime, on target and within budget results. Flexible attitude with respect to work assignments, and new learning opportunities We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What Medical Affairs does at Worldwide Medical Affairs impacts every stage in the lifecycle of a clinical investigation. From Business Development to Regulatory Submissions, members of the MA team support the larger project team and help establish the scientific and medical expertise that characterizes the philosophy here at Worldwide. Activities include direct interactions and presentations with medical and operational personnel from pharmaceutical companies in the process of business development; protocol preparation and country specific feasibility assessments for proposed investigations that inform study design and operational metrics; training of investigative site staff and members of Worldwide project teams on medical or assessment methodology unique to a given study, and the medical monitoring of adherence to the study protocol as well as medical management activities for patients during the course of the trial. Pharmacovigilance activity for adverse event analyses and reporting and a medical writing group are integral part of the service offering. Medical Affairs also partner with other functional groups within the Worldwide organization, the generation of statistical and clinical reports at study conclusion, and scientific/medical assistance in the preparation of study protocols and regulatory submissions. What you will do (Medical Director) Work with global and diverse teams and sponsors from biotech and pharma industries to provide medical expertise, consultation, and support to project teams. Engage with Worldwide teams and our sponsors from protocol development to regulatory submission. Provide Global and/or Regional Medical Monitoring support to assigned clinical studies, including medical management and oversight; training project teams on therapeutic indications and protocol; review of study documents (protocols, safety data, clinical study reports), collaborate with pharmacovigilance to review and process Serious Adverse Events. Represent Worldwide Medical Affairs at investigator and project team meetings. Collaborate with Worldwide Business Development to review and develop proposals, assess feasibility, attend general capabilities, or bid defense meetings. Engage in company and department initiatives, contribute to and participate in company and Medical Affairs programs, trainings and marketing initiatives. Assist in the annual attainment of departmental budget reviews, revenue targets and any other activities. Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety. Assure compliance with ethical, legal and regulatory standards. Obtain medical expertise and knowledge of relevant projects, indications through review of research literature, attendance of relevant internal and external meetings/conferences. What you will bring to the role Medical expertise and good medical judgement. Understanding of medical and clinical research norms and practices Strong organizational and interpersonal skills in a fast-paced and rapidly changing environment. Ability to work independently and as a team member, to exercise independent judgment with sensitivity to decisions requiring supervisory approval, to handle multiple tasks, including rapid response in review of information and documents Excellent written and verbal English and communication skills. Advanced skills in MS Office applications including Microsoft Word, Excel and PowerPoint, willing to learn new technical systems Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements Your background Doctor of medical or osteopathic medicine (MD or OD) degree from an accredited medical education institution, preferably with specialization in the advertised therapeutic area At least 2 years of medical monitoring or study physician role in clinical research or related industry Valid passport and ability to travel as required. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at ! For more information on Worldwide, visit or connect with us on LinkedIn.
Apr 15, 2024
Full time
Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers. Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What Medical Affairs does at Worldwide Medical Affairs impacts every stage in the lifecycle of a clinical investigation. From Business Development to Regulatory Submissions, members of the MA team support the larger project team and help establish the scientific and medical expertise that characterizes the philosophy here at Worldwide. Activities include direct interactions and presentations with medical and operational personnel from pharmaceutical companies in the process of business development; protocol preparation and country specific feasibility assessments for proposed investigations that inform study design and operational metrics; training of investigative site staff and members of Worldwide project teams on medical or assessment methodology unique to a given study, and the medical monitoring of adherence to the study protocol as well as medical management activities for patients during the course of the trial. Pharmacovigilance activity for adverse event analyses and reporting and a medical writing group are integral part of the service offering. Medical Affairs also partner with other functional groups within the Worldwide organization, the generation of statistical and clinical reports at study conclusion, and scientific/medical assistance in the preparation of study protocols and regulatory submissions. What you will do (Medical Director) Work with global and diverse teams and sponsors from biotech and pharma industries to provide medical expertise, consultation, and support to project teams. Engage with Worldwide teams and our sponsors from protocol development to regulatory submission. Provide Global and/or Regional Medical Monitoring support to assigned clinical studies, including medical management and oversight; training project teams on therapeutic indications and protocol; review of study documents (protocols, safety data, clinical study reports), collaborate with pharmacovigilance to review and process Serious Adverse Events. Represent Worldwide Medical Affairs at investigator and project team meetings. Collaborate with Worldwide Business Development to review and develop proposals, assess feasibility, attend general capabilities, or bid defense meetings. Engage in company and department initiatives, contribute to and participate in company and Medical Affairs programs, trainings and marketing initiatives. Assist in the annual attainment of departmental budget reviews, revenue targets and any other activities. Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety. Assure compliance with ethical, legal and regulatory standards. Obtain medical expertise and knowledge of relevant projects, indications through review of research literature, attendance of relevant internal and external meetings/conferences. What you will bring to the role Medical expertise and good medical judgement. Understanding of medical and clinical research norms and practices Strong organizational and interpersonal skills in a fast-paced and rapidly changing environment. Ability to work independently and as a team member, to exercise independent judgment with sensitivity to decisions requiring supervisory approval, to handle multiple tasks, including rapid response in review of information and documents Excellent written and verbal English and communication skills. Advanced skills in MS Office applications including Microsoft Word, Excel and PowerPoint, willing to learn new technical systems Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements Your background Doctor of medical or osteopathic medicine (MD or OD) degree from an accredited medical education institution, preferably with specialization in the advertised therapeutic area At least 2 years of medical monitoring or study physician role in clinical research or related industry Valid passport and ability to travel as required. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at ! For more information on Worldwide, visit or connect with us on LinkedIn.
Employer Whittington Health NHS Trust Employer type NHS Site Whittington Health Town London Salary £58,698 - £65,095 pro-rata per annum inclusive of HCAs Salary period Yearly Closing 16/04/:59 Getting vaccinated, and getting a booster, remains the best defence against COVID-19. We encourage and support staff to get COVID-19 vaccine and a booster dose as and when they are eligible. Please note in order to progress your application, your data will be processed by our 3 rd party recruitment providers - North London Partners Shared Service, who conduct recruitment activities on behalf of Whittington Health NHS Trust. By applying for this role, you accept in the event you are successful that your personal data may be transferred from the Trust to another NHS organisation where your employment transfers within the NHS. This is in accordance with the streamlining programme which is aimed at saving you time and improving efficiencies within the NHS when your employment transfers. Job overview Jointly responsible with the job sharer of the Quality Improvement Lead, the post holder, will provide expertise in improvement methodology and measurement. They will be responsible for the delivery of a trust-wide QI education programme, provision of support and guidance to staff members conducting QI projects, promoting engagement in QI, monitoring QI activities and outputs and promoting the spread of learning from QI activities to other departments. The post holder will play an instrumental role in providing corporate leadership and support for a portfolio of improvement projects, promoting clinical engagement in QI amongst our staff and ensuring that learning from QI projects is shared and spread. The post holder will work with senior leaders in the organisation to develop and enable quality improvement within the Trust. Main duties of the job Support ongoing development and implementation of the Quality Improvement (QI) strategy and review on a yearly basis Lead on the Whittington Health QI programme Contribute and collaborate on Quality Account Priorities and goals, actively leading on relevant projects that form part of the Quality Account Priorities Provide leadership and improvement expertise for an allocated set of QI projects to maximise engagement, impact and learning. Design and deliver teaching in QI on a Trust-wide basis, building organisational QI capacity and capability with other key staff Act as an organisational expert on key elements of the IHI Model for Improvement QI methodology e.g. use of data and measurement in QI Act to maximise the following; co-design and co-production of QI projects with patients, clients and services users engaged in QI activity, communication of QI project outcomes and fostering topic based or service-based QI collaborations. Seek out opportunities and represent the Trust QI function at internal and external events and networks. Develop relationships with NCL QI collaborative and UCLP academic health science network. Facilitate the personal and professional development of staff. Working for our organisation Working as part of the wider Quality Governance team and reporting into the Chief Nurse and Patient Experience office, the role is part of a job share and will support the Trust's aim to improve patient safety, experience and effectiveness through innovation . Detailed job description and main responsibilities MAIN DUTIES Provide operational QI leadership and expertise across the trust. Lead on the QI programme, designing and delivering changes and developments with a Trust-wide impact. Monitor and evolve the QI programme including new ways of working, agreeing and adjusting plans as required. Scope QI initiatives to establish boundaries of the project (and exclusions where appropriate), current state in service provision and develop desired future state. Ensure majority of QI projects develop and use patient and public engagement methodologies. Ensure majority of QI projects promote financial efficiency and productivity benefits. Ensure robust data analysis is used to diagnose gaps and support solution development. Plan and lead QI workshops and QI clinics bringing together diverse groups of staff in a controlled environment to motivate change. Lead on development and execution of communication plans to ensure consistent messages are used to drive improvements and that benefits for patients, staff and the organisation are clearly defined. Regularly interrogate QI project register to ensure themes and outcomes captured and shared. Assist in building, revitalising and maintaining network(s) of QI faculty members to provide peer support to staff undertaking QI projects and initiatives. Work closely with the Quality Governance team to develop and deliver Quality Account priorities and projects Act as an organisational expert on the use of data and measurement for QI Provide expert advice and where necessary, leadership, to staff at all levels in the organisation and on using data and measurement for improvement. This will involve reviewing complex data sets and formulating and amending strategies where there may be more than one course of action. Coach QI/audit leads, clinical and service directors and other directorate staff on analysing and interpreting data for improvement. This will involve reviewing complex data sets and formulating and amending strategies where there may be more than one course of action. Promote and support the publication of Trust QI work using data for improvement. Management support QI projects in all ICSU's across the Trust. Provide high level improvement expertise, leadership and coaching as required to project teams, QI sponsors and any other stakeholders involved in improvement work. Assist senior management to design and embed a structure to allow high priority improvement projects to be supported and thrive within existing infrastructure. Design any specialist learning events and publications that may be required to facilitate the progress of the QI projects and raise awareness of QI project outcomes. Attend project team or any other meetings relevant to the delivery of the project's aims. In each QI project with which they are involved, the post holder will work closely with operational and clinical leaders to: Develop and agree the objective of the QI project. Agree and record desired outcome and process tracking metrics. Develop and implement tests of change using Plan-Do-Study-Act methodology. Manage risks associated with project delivery, in partnership with project operational leads and team, develop and execute controls and mitigations so that project delivery is in line with agreed timescales, escalating where appropriate. Co-ordinate project administration and ensure regular reviews of progress occur e.g. driver diagrams, action plans, progress reports. Lead project communications, including development of posters, presentations, publications and use of social and other media. Ensure that allocated project plan(s) are kept updated and regular reports provided to the Associate Director of Quality Governance, Clinical Effectiveness, Patient Safety and Patient Experience Committees and other relevant executives and committees as required. Monitor progress of high priority projects and collaborate with relevant internal and external stakeholders to ensure progress in improvement work is maintained. Develop and foster relationships with staff in these project teams and manage these relationships such that team members proactively seek support. Actively engage clinical and non-clinical stakeholders who may be key to the project(s) achieving its aim(s). Collate and present information relating to the progress of these projects at internal and external forums and meetings. Coach and facilitate improvement project teams to promote and publish work being undertaken. Design and deliver teaching in QI on a Trust-wide basis. Help support the development of QI capacity and capability within the organisation. Teach improvement science, including the use of measurement and data, at internal training events as required. These include, but are not limited to QI Enabled programme and bespoke learning events. Co-produce teaching and briefing materials and agendas/course training plans for training events. Evaluate and continue to develop in-house training, coaching and peer support packages on QI. Research and adapt Model for Improvement resources for use in service specific and Trust-wide learning and development activities. Develop and implement methods of assessing the impact and outcome from teaching, learning and development activities. Support the development and deployment of the QI strategy Support the development of improvement priorities in line with the business planning cycle in the Trust. Support ICSUs to integrate QI into their quality, service delivery and cost improvement plans. Ensure majority of QI projects are patient centred and involve patient/carer representation in their design and implementation. Assist in engaging with a wide range of internal and external stakeholders to shape the Trust QI strategy and implementation plan. This will involve analysing and interpreting data in order to prioritise service improvements. . click apply for full job details
Apr 15, 2024
Full time
Employer Whittington Health NHS Trust Employer type NHS Site Whittington Health Town London Salary £58,698 - £65,095 pro-rata per annum inclusive of HCAs Salary period Yearly Closing 16/04/:59 Getting vaccinated, and getting a booster, remains the best defence against COVID-19. We encourage and support staff to get COVID-19 vaccine and a booster dose as and when they are eligible. Please note in order to progress your application, your data will be processed by our 3 rd party recruitment providers - North London Partners Shared Service, who conduct recruitment activities on behalf of Whittington Health NHS Trust. By applying for this role, you accept in the event you are successful that your personal data may be transferred from the Trust to another NHS organisation where your employment transfers within the NHS. This is in accordance with the streamlining programme which is aimed at saving you time and improving efficiencies within the NHS when your employment transfers. Job overview Jointly responsible with the job sharer of the Quality Improvement Lead, the post holder, will provide expertise in improvement methodology and measurement. They will be responsible for the delivery of a trust-wide QI education programme, provision of support and guidance to staff members conducting QI projects, promoting engagement in QI, monitoring QI activities and outputs and promoting the spread of learning from QI activities to other departments. The post holder will play an instrumental role in providing corporate leadership and support for a portfolio of improvement projects, promoting clinical engagement in QI amongst our staff and ensuring that learning from QI projects is shared and spread. The post holder will work with senior leaders in the organisation to develop and enable quality improvement within the Trust. Main duties of the job Support ongoing development and implementation of the Quality Improvement (QI) strategy and review on a yearly basis Lead on the Whittington Health QI programme Contribute and collaborate on Quality Account Priorities and goals, actively leading on relevant projects that form part of the Quality Account Priorities Provide leadership and improvement expertise for an allocated set of QI projects to maximise engagement, impact and learning. Design and deliver teaching in QI on a Trust-wide basis, building organisational QI capacity and capability with other key staff Act as an organisational expert on key elements of the IHI Model for Improvement QI methodology e.g. use of data and measurement in QI Act to maximise the following; co-design and co-production of QI projects with patients, clients and services users engaged in QI activity, communication of QI project outcomes and fostering topic based or service-based QI collaborations. Seek out opportunities and represent the Trust QI function at internal and external events and networks. Develop relationships with NCL QI collaborative and UCLP academic health science network. Facilitate the personal and professional development of staff. Working for our organisation Working as part of the wider Quality Governance team and reporting into the Chief Nurse and Patient Experience office, the role is part of a job share and will support the Trust's aim to improve patient safety, experience and effectiveness through innovation . Detailed job description and main responsibilities MAIN DUTIES Provide operational QI leadership and expertise across the trust. Lead on the QI programme, designing and delivering changes and developments with a Trust-wide impact. Monitor and evolve the QI programme including new ways of working, agreeing and adjusting plans as required. Scope QI initiatives to establish boundaries of the project (and exclusions where appropriate), current state in service provision and develop desired future state. Ensure majority of QI projects develop and use patient and public engagement methodologies. Ensure majority of QI projects promote financial efficiency and productivity benefits. Ensure robust data analysis is used to diagnose gaps and support solution development. Plan and lead QI workshops and QI clinics bringing together diverse groups of staff in a controlled environment to motivate change. Lead on development and execution of communication plans to ensure consistent messages are used to drive improvements and that benefits for patients, staff and the organisation are clearly defined. Regularly interrogate QI project register to ensure themes and outcomes captured and shared. Assist in building, revitalising and maintaining network(s) of QI faculty members to provide peer support to staff undertaking QI projects and initiatives. Work closely with the Quality Governance team to develop and deliver Quality Account priorities and projects Act as an organisational expert on the use of data and measurement for QI Provide expert advice and where necessary, leadership, to staff at all levels in the organisation and on using data and measurement for improvement. This will involve reviewing complex data sets and formulating and amending strategies where there may be more than one course of action. Coach QI/audit leads, clinical and service directors and other directorate staff on analysing and interpreting data for improvement. This will involve reviewing complex data sets and formulating and amending strategies where there may be more than one course of action. Promote and support the publication of Trust QI work using data for improvement. Management support QI projects in all ICSU's across the Trust. Provide high level improvement expertise, leadership and coaching as required to project teams, QI sponsors and any other stakeholders involved in improvement work. Assist senior management to design and embed a structure to allow high priority improvement projects to be supported and thrive within existing infrastructure. Design any specialist learning events and publications that may be required to facilitate the progress of the QI projects and raise awareness of QI project outcomes. Attend project team or any other meetings relevant to the delivery of the project's aims. In each QI project with which they are involved, the post holder will work closely with operational and clinical leaders to: Develop and agree the objective of the QI project. Agree and record desired outcome and process tracking metrics. Develop and implement tests of change using Plan-Do-Study-Act methodology. Manage risks associated with project delivery, in partnership with project operational leads and team, develop and execute controls and mitigations so that project delivery is in line with agreed timescales, escalating where appropriate. Co-ordinate project administration and ensure regular reviews of progress occur e.g. driver diagrams, action plans, progress reports. Lead project communications, including development of posters, presentations, publications and use of social and other media. Ensure that allocated project plan(s) are kept updated and regular reports provided to the Associate Director of Quality Governance, Clinical Effectiveness, Patient Safety and Patient Experience Committees and other relevant executives and committees as required. Monitor progress of high priority projects and collaborate with relevant internal and external stakeholders to ensure progress in improvement work is maintained. Develop and foster relationships with staff in these project teams and manage these relationships such that team members proactively seek support. Actively engage clinical and non-clinical stakeholders who may be key to the project(s) achieving its aim(s). Collate and present information relating to the progress of these projects at internal and external forums and meetings. Coach and facilitate improvement project teams to promote and publish work being undertaken. Design and deliver teaching in QI on a Trust-wide basis. Help support the development of QI capacity and capability within the organisation. Teach improvement science, including the use of measurement and data, at internal training events as required. These include, but are not limited to QI Enabled programme and bespoke learning events. Co-produce teaching and briefing materials and agendas/course training plans for training events. Evaluate and continue to develop in-house training, coaching and peer support packages on QI. Research and adapt Model for Improvement resources for use in service specific and Trust-wide learning and development activities. Develop and implement methods of assessing the impact and outcome from teaching, learning and development activities. Support the development and deployment of the QI strategy Support the development of improvement priorities in line with the business planning cycle in the Trust. Support ICSUs to integrate QI into their quality, service delivery and cost improvement plans. Ensure majority of QI projects are patient centred and involve patient/carer representation in their design and implementation. Assist in engaging with a wide range of internal and external stakeholders to shape the Trust QI strategy and implementation plan. This will involve analysing and interpreting data in order to prioritise service improvements. . click apply for full job details
ABOUT THE ROLE At DSV we're looking for future Founders, entrepreneurially minded individuals with industry-specific technical and commercial domain expertise eager to solve urgent unmet challenges through venture building. You will be joining a newly incorporated company as a Co-Founder, working closely with Dr. Loïc Roux , who has been building the company OligoTune through DSV's venture creation programme as a Founder-in-Residence. Over the last 10 months, Loïc has worked with DSV, devising and de-risking a novel RNA-based approach to overcome immune suppression in the tumour microenvironment. This venture is now close to being launched, and once incorporated with pre-seed investment from DSV, the co-founders will own the majority stake in the business and continue receiving support from the DSV team post-spinout. By joining Loïc at this stage, you will be driving all stages of early company growth, with a focus on tumour biology, immunology and pre-clinical development. In addition, you will be teamed up with our Venture Partner for this opportunity, Dr. Stevel Powell , alongside a growing scientific advisory board. THE OPPORTUNITY AREA Immunotherapies, especially antibody-based immune checkpoint inhibitors (ICIs) and CAR-T cell therapy have revolutionised cancer treatment with incredible results in a subset of solid tumours and in blood cancers, respectively. Despite this widely recognised success and paradigm shift in cancer treatment, these therapies still only increase median patient survival by limited degrees, often by only 10-20% vs. chemotherapies, or they only work in selected patient subsets with variable predictability. In addition, the development of resistance mechanisms, such as enhanced immune suppression, is frequent, as a result of selective pressure on the cancer to evade this method of detection by the immune system. This leads to therapeutic resistance initially and, later, recurrence. We are still far from enabling immunotherapies to work across all cancers, or in all patients. Immune suppression is caused by a variety of mechanisms within the tumour microenvironment (TME) of solid tumours, and is a well-known cause for failure of ICIs. The lack of TME-specific cell markers means that targeted approaches (e.g. to inhibit or deplete TME cell types) incur significant autoimmune-like side effects on the same cells in other parts of the body, rendering these therapies intolerable or unusable in a substantial proportion of patients - an issue that typically compounds with combinatorial immunotherapies. WHAT WE ARE BUILDING In collaboration with our partner Cancer Research Horizons, we are seeking to build the 'holy grail' company, solving these above challenges by simultaneously reprogramming multiple problematic cell types in the tumour microenvironment, while preventing systemic toxicities associated with current treatments. We believe we can build technology that can revert the immune suppressive environment of solid tumours and transform them into a susceptible state where the full power of ICIs can be unleashed - even in patients who would otherwise not respond (or be eligible for) conventional ICI therapies. The collaboration with Cancer Research Horizons Therapeutic Innovation brings a highly-skilled team of scientific leaders and hands-on experts to drive the creation of this venture and realise a streamlined pathway for this therapeutic approach to the clinic. DSV will provide ongoing support in venture creation and growth throughout the process, and experimental work will be supported through in-kind contributions at Cancer Research Horizons' state-of-the-art research facilities in Cambridge, UK. We are looking for a passionate and motivated co-founder with strong scientific expertise and track-record in immunology or immuno-oncology, to drive forward the science of this early-stage biotech. The successful candidate will co-lead this company and be a key player in driving the company vision, strategy and market positioning, as well as in conducting and overseeing research and development activities. Key roles will include: Providing scientific leadership and expertise in immunology and immuno-oncology, guiding the strategic direction of research and development efforts to advance the company's scientific objectives; Collaborating with the co-founder and broader team to shape the company's vision, strategy, and market positioning, leveraging deep immunological knowledge to identify opportunities and drive innovation; Overseeing and actively participating in research and development activities by: Designing, refining and optimising the experimental work plan to ensure successful execution and generation of high-quality scientific data; Orchestrating the development of cutting-edge oligonucleotide therapeutics for critical in vitro and ex vivo translational studies in order to assess efficacy, toxicology and PK/PD profiles of those drugs in the context of our technology; Systematically screening and defining a target selection pipeline Developing in vivo biodistribution and efficacy study plans and overseeing these studies; Guiding the development and integration of new assays and technologies, to continuously improve our technology; Crafting compelling data packages and presentations for investor conversations; Taking responsibility for the financial planning, resource allocation, and management of projects and contractual research; Cultivating robust relations with strategic partners and collaborators, suppliers and organisations to ensure accelerated and co-ordinated translational research; Identifying, developing, and safeguarding novel intellectual property, ensuring the protection and commercialisation of valuable innovations; Ensure compliance with regulatory requirements and standards relevant to immunology and immuno-oncology Identifying and mitigating risks, making informed decisions based on scientific evidence and company considerations, and adapting strategies as needed Overall, the co-founder will play a pivotal role in shaping the scientific direction, growth, and success of the company, driving forward the science of immunology and immuno-oncology to make meaningful contributions to patients' lives. WHO SHOULD APPLY Essential (must-have): You have a PhD and/or MD background in immunology or immuno-oncology. You are driven by unsolved challenges in medicine, especially oncology and immunotherapy, and have the ambition to work with a team to build new solutions resulting in curative therapies You have deep hands-on experience in functional immunological assays, particularly with tumour microenvironment immune cell types (ie. T cells, Tregs, macrophages, others) A deep understanding of cancer immunotherapy mechanisms and associated challenges at the biological, clinical, technical, regulatory and competitive levels. Drug discovery or (pre-)clinical development expertise Target identification and validation applied to immuno-oncology High level of organisational skills, with the ability to manage a broad range of tasks simultaneously and under pressure Capable of critical thinking and a high level of attention to detail Excellent communication skills Organised and hard-working, with a strong eye for detail and able to work as part of a team Ability to learn quickly and work in a fast-paced environment Deep biological understanding of immune cell biology, particularly immune cells present within the tumour microenvironment You are innovative, creative, and guided by first-principles thinking You have clear entrepreneurial spirit (demonstrated through impactful innovation) and the desire to create a company developing solutions for challenging cancers . Preferred (nice-to-have): Bioinformatics and data analysis skills Track record of high quality publications in the field, or thought leadership in the field High level industry experience in either pharma, biotech, scientific start-ups, life sciences consulting, life sciences VC, or have previously been an inventor/contributor on patents, etc. Fundraising and commercial expertise, particularly in a VC setting OUR OFFER: By joining DSV, you'll be joining a team of operators who have founded companies and led translation of science at some of the most respected universities, charities, funds and government agencies. 2/3 of the team have founded or led a company at C-suite and 65% have a PhD. Our team dedicate several hours every week to each Founder or founding team to provide tailored guidance, resources and feedback covering every aspect of what it takes to successfully launch a new venture from both the tech and commercial perspectives: We provide optimised, purpose-built, proprietary tools, resources and processes to help create high-impact ventures from scratch, using our venture creation methodology. We draw on opportunity area specific know-how provided by our network of Partners and Advisors; We provide £250k launch investment (subject to Investment Committee approval) to incorporate the new venture and develop early proof-of-concept data that's needed to attract high profile VCs as well as non-dilutive grant funding. We provide guaranteed income of £4,166 per month paid to each Founder-in-Residence as a consultancy fee until the company is launched and the pre-seed investment is secured; You and the Founder-in-Residence, together with any additional co-founders, will own a majority equity stake in the company; . click apply for full job details
Apr 15, 2024
Full time
ABOUT THE ROLE At DSV we're looking for future Founders, entrepreneurially minded individuals with industry-specific technical and commercial domain expertise eager to solve urgent unmet challenges through venture building. You will be joining a newly incorporated company as a Co-Founder, working closely with Dr. Loïc Roux , who has been building the company OligoTune through DSV's venture creation programme as a Founder-in-Residence. Over the last 10 months, Loïc has worked with DSV, devising and de-risking a novel RNA-based approach to overcome immune suppression in the tumour microenvironment. This venture is now close to being launched, and once incorporated with pre-seed investment from DSV, the co-founders will own the majority stake in the business and continue receiving support from the DSV team post-spinout. By joining Loïc at this stage, you will be driving all stages of early company growth, with a focus on tumour biology, immunology and pre-clinical development. In addition, you will be teamed up with our Venture Partner for this opportunity, Dr. Stevel Powell , alongside a growing scientific advisory board. THE OPPORTUNITY AREA Immunotherapies, especially antibody-based immune checkpoint inhibitors (ICIs) and CAR-T cell therapy have revolutionised cancer treatment with incredible results in a subset of solid tumours and in blood cancers, respectively. Despite this widely recognised success and paradigm shift in cancer treatment, these therapies still only increase median patient survival by limited degrees, often by only 10-20% vs. chemotherapies, or they only work in selected patient subsets with variable predictability. In addition, the development of resistance mechanisms, such as enhanced immune suppression, is frequent, as a result of selective pressure on the cancer to evade this method of detection by the immune system. This leads to therapeutic resistance initially and, later, recurrence. We are still far from enabling immunotherapies to work across all cancers, or in all patients. Immune suppression is caused by a variety of mechanisms within the tumour microenvironment (TME) of solid tumours, and is a well-known cause for failure of ICIs. The lack of TME-specific cell markers means that targeted approaches (e.g. to inhibit or deplete TME cell types) incur significant autoimmune-like side effects on the same cells in other parts of the body, rendering these therapies intolerable or unusable in a substantial proportion of patients - an issue that typically compounds with combinatorial immunotherapies. WHAT WE ARE BUILDING In collaboration with our partner Cancer Research Horizons, we are seeking to build the 'holy grail' company, solving these above challenges by simultaneously reprogramming multiple problematic cell types in the tumour microenvironment, while preventing systemic toxicities associated with current treatments. We believe we can build technology that can revert the immune suppressive environment of solid tumours and transform them into a susceptible state where the full power of ICIs can be unleashed - even in patients who would otherwise not respond (or be eligible for) conventional ICI therapies. The collaboration with Cancer Research Horizons Therapeutic Innovation brings a highly-skilled team of scientific leaders and hands-on experts to drive the creation of this venture and realise a streamlined pathway for this therapeutic approach to the clinic. DSV will provide ongoing support in venture creation and growth throughout the process, and experimental work will be supported through in-kind contributions at Cancer Research Horizons' state-of-the-art research facilities in Cambridge, UK. We are looking for a passionate and motivated co-founder with strong scientific expertise and track-record in immunology or immuno-oncology, to drive forward the science of this early-stage biotech. The successful candidate will co-lead this company and be a key player in driving the company vision, strategy and market positioning, as well as in conducting and overseeing research and development activities. Key roles will include: Providing scientific leadership and expertise in immunology and immuno-oncology, guiding the strategic direction of research and development efforts to advance the company's scientific objectives; Collaborating with the co-founder and broader team to shape the company's vision, strategy, and market positioning, leveraging deep immunological knowledge to identify opportunities and drive innovation; Overseeing and actively participating in research and development activities by: Designing, refining and optimising the experimental work plan to ensure successful execution and generation of high-quality scientific data; Orchestrating the development of cutting-edge oligonucleotide therapeutics for critical in vitro and ex vivo translational studies in order to assess efficacy, toxicology and PK/PD profiles of those drugs in the context of our technology; Systematically screening and defining a target selection pipeline Developing in vivo biodistribution and efficacy study plans and overseeing these studies; Guiding the development and integration of new assays and technologies, to continuously improve our technology; Crafting compelling data packages and presentations for investor conversations; Taking responsibility for the financial planning, resource allocation, and management of projects and contractual research; Cultivating robust relations with strategic partners and collaborators, suppliers and organisations to ensure accelerated and co-ordinated translational research; Identifying, developing, and safeguarding novel intellectual property, ensuring the protection and commercialisation of valuable innovations; Ensure compliance with regulatory requirements and standards relevant to immunology and immuno-oncology Identifying and mitigating risks, making informed decisions based on scientific evidence and company considerations, and adapting strategies as needed Overall, the co-founder will play a pivotal role in shaping the scientific direction, growth, and success of the company, driving forward the science of immunology and immuno-oncology to make meaningful contributions to patients' lives. WHO SHOULD APPLY Essential (must-have): You have a PhD and/or MD background in immunology or immuno-oncology. You are driven by unsolved challenges in medicine, especially oncology and immunotherapy, and have the ambition to work with a team to build new solutions resulting in curative therapies You have deep hands-on experience in functional immunological assays, particularly with tumour microenvironment immune cell types (ie. T cells, Tregs, macrophages, others) A deep understanding of cancer immunotherapy mechanisms and associated challenges at the biological, clinical, technical, regulatory and competitive levels. Drug discovery or (pre-)clinical development expertise Target identification and validation applied to immuno-oncology High level of organisational skills, with the ability to manage a broad range of tasks simultaneously and under pressure Capable of critical thinking and a high level of attention to detail Excellent communication skills Organised and hard-working, with a strong eye for detail and able to work as part of a team Ability to learn quickly and work in a fast-paced environment Deep biological understanding of immune cell biology, particularly immune cells present within the tumour microenvironment You are innovative, creative, and guided by first-principles thinking You have clear entrepreneurial spirit (demonstrated through impactful innovation) and the desire to create a company developing solutions for challenging cancers . Preferred (nice-to-have): Bioinformatics and data analysis skills Track record of high quality publications in the field, or thought leadership in the field High level industry experience in either pharma, biotech, scientific start-ups, life sciences consulting, life sciences VC, or have previously been an inventor/contributor on patents, etc. Fundraising and commercial expertise, particularly in a VC setting OUR OFFER: By joining DSV, you'll be joining a team of operators who have founded companies and led translation of science at some of the most respected universities, charities, funds and government agencies. 2/3 of the team have founded or led a company at C-suite and 65% have a PhD. Our team dedicate several hours every week to each Founder or founding team to provide tailored guidance, resources and feedback covering every aspect of what it takes to successfully launch a new venture from both the tech and commercial perspectives: We provide optimised, purpose-built, proprietary tools, resources and processes to help create high-impact ventures from scratch, using our venture creation methodology. We draw on opportunity area specific know-how provided by our network of Partners and Advisors; We provide £250k launch investment (subject to Investment Committee approval) to incorporate the new venture and develop early proof-of-concept data that's needed to attract high profile VCs as well as non-dilutive grant funding. We provide guaranteed income of £4,166 per month paid to each Founder-in-Residence as a consultancy fee until the company is launched and the pre-seed investment is secured; You and the Founder-in-Residence, together with any additional co-founders, will own a majority equity stake in the company; . click apply for full job details
Our Parkinson's Virtual Biotech is our flagship programme for creating new treatments for Parkinson's, based on the needs and priorities of people living with Parkinson's. We are deploying £5M per year to fund preclinical and early clinical stage projects in biotechs and contract research organisations to bring new treatments to people living with Parkinson's. Please click here to find out more about the Parkinson's Virtual Biotech. About the role You'll bring expert knowledge of Parkinson's pathophysiology, pharmacology and therapeutics development to all our VB activities. These include primarily the sourcing and evaluation of new project proposals, and then the funding and management of the most promising ones. You will liaise extensively with the Parkinson's community and external partners, and maintain up to date knowledge in the field. With your years of preclinical disease-area expertise you will work alongside your colleagues with backgrounds in medicinal chemistry and biological aspects of drug discovery, clinical research and biotech finance. What you'll do: Provide expert knowledge of Parkinson's pathophysiology, in vitro and in vivo models of aspects of Parkinson's and neurodegeneration, to all our activities. Solicit external proposals for new projects and develop internal project proposals, and bring new initiatives and working practices to the Virtual Biotech, as appropriate Critically review the target validation and preclinical pharmacology aspects of internal and external project proposals Participate in joint steering committees and other advisory meetings, providing expert scientific and strategic insight Interact with people with Parkinson's and involve them in projects in order to increase the opportunities to deliver new drugs that meet unmet medical needs What you'll bring: Widely respected expertise in the study of Parkinson's pathophysiology and preclinical pharmacology with at least 8 years post-doctorate experience in the field, and a track record of proposing new projects and securing the required funding Doctoral degree in a relevant discipline (Ph.D., M.D., D.Phil.) Familiarity with small molecule drug discovery principles and practices including use of Parkinson's disease models Excellent communication skills, with the ability to present complex information in suitable formats, including project proposals/reports, for both scientific and lay audiences Significant experience in project management and leadership skills from initiation to completion/review, with the ability to lead cross-functional teams This is an exciting time for Parkinson's UK and we would love you to join us! Please apply by sending us your CV, together with a detailed supporting statement which will fully demonstrate how you meet all the criteria of the role, as stated in the "What you'll bring" section of the job description. Anyone can get Parkinson's. It's vital that the people who work for Parkinson's UK are representative of our diverse community. We actively encourage people from all sections of the community to apply, regardless of race, ethnicity, gender identity, age, disability, sexual orientation, or religion.
Apr 15, 2024
Full time
Our Parkinson's Virtual Biotech is our flagship programme for creating new treatments for Parkinson's, based on the needs and priorities of people living with Parkinson's. We are deploying £5M per year to fund preclinical and early clinical stage projects in biotechs and contract research organisations to bring new treatments to people living with Parkinson's. Please click here to find out more about the Parkinson's Virtual Biotech. About the role You'll bring expert knowledge of Parkinson's pathophysiology, pharmacology and therapeutics development to all our VB activities. These include primarily the sourcing and evaluation of new project proposals, and then the funding and management of the most promising ones. You will liaise extensively with the Parkinson's community and external partners, and maintain up to date knowledge in the field. With your years of preclinical disease-area expertise you will work alongside your colleagues with backgrounds in medicinal chemistry and biological aspects of drug discovery, clinical research and biotech finance. What you'll do: Provide expert knowledge of Parkinson's pathophysiology, in vitro and in vivo models of aspects of Parkinson's and neurodegeneration, to all our activities. Solicit external proposals for new projects and develop internal project proposals, and bring new initiatives and working practices to the Virtual Biotech, as appropriate Critically review the target validation and preclinical pharmacology aspects of internal and external project proposals Participate in joint steering committees and other advisory meetings, providing expert scientific and strategic insight Interact with people with Parkinson's and involve them in projects in order to increase the opportunities to deliver new drugs that meet unmet medical needs What you'll bring: Widely respected expertise in the study of Parkinson's pathophysiology and preclinical pharmacology with at least 8 years post-doctorate experience in the field, and a track record of proposing new projects and securing the required funding Doctoral degree in a relevant discipline (Ph.D., M.D., D.Phil.) Familiarity with small molecule drug discovery principles and practices including use of Parkinson's disease models Excellent communication skills, with the ability to present complex information in suitable formats, including project proposals/reports, for both scientific and lay audiences Significant experience in project management and leadership skills from initiation to completion/review, with the ability to lead cross-functional teams This is an exciting time for Parkinson's UK and we would love you to join us! Please apply by sending us your CV, together with a detailed supporting statement which will fully demonstrate how you meet all the criteria of the role, as stated in the "What you'll bring" section of the job description. Anyone can get Parkinson's. It's vital that the people who work for Parkinson's UK are representative of our diverse community. We actively encourage people from all sections of the community to apply, regardless of race, ethnicity, gender identity, age, disability, sexual orientation, or religion.
These positions have a starting salary of £48,105 per annum pro-rata to £51,923 (inclusive of market supplement) (NHS Band 7 equivalent) for working 36 hours per week across 42 weeks of the year. We will also consider applicants who would like to work a 28.80 hour week for 42 weeks a year. We are excited to be offering opportunities for Highly Experienced Speech and Language Therapists to join our leadership team! These position are based within the team who work in mainstream and specialist schools across our four quadrants, and with severe to profoundly deaf preschool children and their families. Our four quadrants are: North West (covering Woking, Runnymede and Surrey Heath) South West (covering Guildford and Waverley) North East (covering Epsom & Ewell, Spelthorne and Elmbridge) South East (covering Reigate & Banstead, Mole Valley and Tandridge) Rewards and Benefits This is 42 week post with 10 weeks non term time, there are 15 additional days during schools holidays for CPD, supervision and project working An extensive Employee Assistance Programme (EAP) to support health and wellbeing Paid fees for RCSLT membership and HCPC Up to 5 days of carer's leave per year Paternity, adoption and dependants leave A generous local government salary related pension Lifestyle discounts including gym, travel, shopping and many more 2 paid volunteering days plus 1 team volunteering day per year Learning and development hub where you can access a wealth of resources A team of students, therapists and assistants led by a Therapies Manager who is an SLT Comprehensive clinical supervision programme including a buddy, 1:1 meetings with line manager, extensive in house training programme and formal external training opportunities, access to clinical effectiveness groups, case study groups, termly study days, encouragement to join and attend CEN's relating to practice About the Team The School-Aged SLT Service is part of Surrey's local offer to support the Special Educational Needs and Disabilities of children and young people within mainstream schools and specialist provision. The Service is part of the Inclusion and Additional Needs Team in Surrey's Children, Families and Lifelong Learning directorate. We are a large team working across the four geographical quadrants of Surrey, each managed by a Quadrant Lead. There are a team of Highly Specialist / Clinical Team Leads in each geographical area who work together to support the team and support service development. Our aim is for children and young people with speech, language and communication needs to receive the right support at the right time. We do this through our universal offer of advice, signposting and training, a targeted offer of modelling and coaching and specialist assessment and intervention for those needing this level of support. We aim to equip families and professionals with the skills and resources to work together to help and support children with SLCN. We work with children and young people with EHCPs and those at SEN support. The Opportunities Post 1: Experienced SLT in the field of deafness to become one of two Team Leads for our specialist deaf team in the North East of Surrey Post 2: Experienced SLT with a passion for working with children and young people in secondary and post-16 settings to lead new pathways for supporting CYP within this age group in the South West of Surrey Post 3: Experienced SLT to lead the teams working in our Specialist Schools for Children with additional needs in the North West of Surrey As a Highly Specialist SLT / Clinical Team Lead you will hold your own specialist clinical caseload in an area of your expertise, you will also provide support for others working within that specialism e.g. deafness, secondary, post 16, Specialist Schools for children with additional needs. You will have a management role in one of the Quadrant teams which includes working alongside the other Team Leads to support and develop an enthusiastic and friendly team who work in mainstream and specialist schools across the quadrant and with severe to profoundly deaf preschool children and their families. Through a joint up approach with colleagues across Surrey, you will ensure the wider team is informed of current research and evidence base, and that clinical practice is of high quality. In your role you will provide clinical supervision and line management to members of the SLT Team and support with second opinions, observation, training and shadowing opportunities for colleagues. You will work with management on the operational and strategic development of services to our schools across Surrey. You will also provide advice at educational panels. Shortlisting Criteria To be considered for shortlisting for this position, your application will clearly evidence the following: SLT background with at least 5 years post graduate experience, and specific experience and training around supporting pupils with deafness, school- aged secondary pupils, post 16, working in Specialist Schools for children with additional needs. Knowledge of the National Curriculum and Code of Practice and experience in working within a tiered model of support e.g. Balance Model Experience of working within an effective multidisciplinary team Flexibility to adapt both clinical approach and communication style to ensure that assessment, reports, therapy inputs and outcomes are functional and client centred Experience of training and positively influencing practice in large staff teams and line managing / supporting others A continuing commitment to learning and development of self and others particularly with regard to the evidence base and research A BSc (Hons) degree or masters in Speech and Language Therapy Registered membership of the HCPC and RCoSLT The job advert closes at 23:59 on 26.04.2024 with interviews planned for week commencing 6th May 2024.
Apr 13, 2024
Full time
These positions have a starting salary of £48,105 per annum pro-rata to £51,923 (inclusive of market supplement) (NHS Band 7 equivalent) for working 36 hours per week across 42 weeks of the year. We will also consider applicants who would like to work a 28.80 hour week for 42 weeks a year. We are excited to be offering opportunities for Highly Experienced Speech and Language Therapists to join our leadership team! These position are based within the team who work in mainstream and specialist schools across our four quadrants, and with severe to profoundly deaf preschool children and their families. Our four quadrants are: North West (covering Woking, Runnymede and Surrey Heath) South West (covering Guildford and Waverley) North East (covering Epsom & Ewell, Spelthorne and Elmbridge) South East (covering Reigate & Banstead, Mole Valley and Tandridge) Rewards and Benefits This is 42 week post with 10 weeks non term time, there are 15 additional days during schools holidays for CPD, supervision and project working An extensive Employee Assistance Programme (EAP) to support health and wellbeing Paid fees for RCSLT membership and HCPC Up to 5 days of carer's leave per year Paternity, adoption and dependants leave A generous local government salary related pension Lifestyle discounts including gym, travel, shopping and many more 2 paid volunteering days plus 1 team volunteering day per year Learning and development hub where you can access a wealth of resources A team of students, therapists and assistants led by a Therapies Manager who is an SLT Comprehensive clinical supervision programme including a buddy, 1:1 meetings with line manager, extensive in house training programme and formal external training opportunities, access to clinical effectiveness groups, case study groups, termly study days, encouragement to join and attend CEN's relating to practice About the Team The School-Aged SLT Service is part of Surrey's local offer to support the Special Educational Needs and Disabilities of children and young people within mainstream schools and specialist provision. The Service is part of the Inclusion and Additional Needs Team in Surrey's Children, Families and Lifelong Learning directorate. We are a large team working across the four geographical quadrants of Surrey, each managed by a Quadrant Lead. There are a team of Highly Specialist / Clinical Team Leads in each geographical area who work together to support the team and support service development. Our aim is for children and young people with speech, language and communication needs to receive the right support at the right time. We do this through our universal offer of advice, signposting and training, a targeted offer of modelling and coaching and specialist assessment and intervention for those needing this level of support. We aim to equip families and professionals with the skills and resources to work together to help and support children with SLCN. We work with children and young people with EHCPs and those at SEN support. The Opportunities Post 1: Experienced SLT in the field of deafness to become one of two Team Leads for our specialist deaf team in the North East of Surrey Post 2: Experienced SLT with a passion for working with children and young people in secondary and post-16 settings to lead new pathways for supporting CYP within this age group in the South West of Surrey Post 3: Experienced SLT to lead the teams working in our Specialist Schools for Children with additional needs in the North West of Surrey As a Highly Specialist SLT / Clinical Team Lead you will hold your own specialist clinical caseload in an area of your expertise, you will also provide support for others working within that specialism e.g. deafness, secondary, post 16, Specialist Schools for children with additional needs. You will have a management role in one of the Quadrant teams which includes working alongside the other Team Leads to support and develop an enthusiastic and friendly team who work in mainstream and specialist schools across the quadrant and with severe to profoundly deaf preschool children and their families. Through a joint up approach with colleagues across Surrey, you will ensure the wider team is informed of current research and evidence base, and that clinical practice is of high quality. In your role you will provide clinical supervision and line management to members of the SLT Team and support with second opinions, observation, training and shadowing opportunities for colleagues. You will work with management on the operational and strategic development of services to our schools across Surrey. You will also provide advice at educational panels. Shortlisting Criteria To be considered for shortlisting for this position, your application will clearly evidence the following: SLT background with at least 5 years post graduate experience, and specific experience and training around supporting pupils with deafness, school- aged secondary pupils, post 16, working in Specialist Schools for children with additional needs. Knowledge of the National Curriculum and Code of Practice and experience in working within a tiered model of support e.g. Balance Model Experience of working within an effective multidisciplinary team Flexibility to adapt both clinical approach and communication style to ensure that assessment, reports, therapy inputs and outcomes are functional and client centred Experience of training and positively influencing practice in large staff teams and line managing / supporting others A continuing commitment to learning and development of self and others particularly with regard to the evidence base and research A BSc (Hons) degree or masters in Speech and Language Therapy Registered membership of the HCPC and RCoSLT The job advert closes at 23:59 on 26.04.2024 with interviews planned for week commencing 6th May 2024.
Job Description: Associate Director, Medical Monitor, Vaccines ROLE SUMMARY The clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. RESPONSIBILITIES Accountable for safety across the study: Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the "Safety Data Review Guide - for Clinicians." Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context. Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study. Communicates safety information to sites across the study and provides responses to questions on safety. Protocol design and strategy: Contributes towards the medical input during protocol development and updates to the clinical development plan. Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document ICD , etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs. Provides medical input into country feasibility. Support study team With supervision of medical monitor (director/Sr director) provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed. Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied. Works with study team to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing. Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting. Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Interacts with DMCs and steering committees as required. Notifies appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events. Monitor investigator compliance with protocol and regulatory requirements. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Supports the program team: Under supervision (director/Sr director) authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report). May co-author abstracts, posters, presentations, and publications. May contribute budget execution of protocols. Interact with regulatory authorities, key opinion leaders, and principal investigators: May support Clinical Regulatory Authority interactions accountable for providing responses. Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials. BASIC QUALIFICATIONS Medical degree (M.D./D.O. or equivalent). Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year. Possesses the ability to critically evaluate medical/scientific information. Excellent written an oral communication. Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast pace and changing environment. PREFERRED QUALIFICATIONS Documented work experience/knowledge of statistics Training and experience in infectious diseases and/or infection control in the hospital setting. Experience with investigational clinical trials. No pharmaceutical industry experience required. Work Location Assignment: On Premise (Marlow)
Apr 12, 2024
Full time
Job Description: Associate Director, Medical Monitor, Vaccines ROLE SUMMARY The clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. RESPONSIBILITIES Accountable for safety across the study: Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the "Safety Data Review Guide - for Clinicians." Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context. Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study. Communicates safety information to sites across the study and provides responses to questions on safety. Protocol design and strategy: Contributes towards the medical input during protocol development and updates to the clinical development plan. Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document ICD , etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs. Provides medical input into country feasibility. Support study team With supervision of medical monitor (director/Sr director) provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed. Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied. Works with study team to ensure high quality of data e.g., appropriate patient population, adequacy of clinical assessments as study is ongoing. Contributes to medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting. Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Interacts with DMCs and steering committees as required. Notifies appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events. Monitor investigator compliance with protocol and regulatory requirements. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Supports the program team: Under supervision (director/Sr director) authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report). May co-author abstracts, posters, presentations, and publications. May contribute budget execution of protocols. Interact with regulatory authorities, key opinion leaders, and principal investigators: May support Clinical Regulatory Authority interactions accountable for providing responses. Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials. BASIC QUALIFICATIONS Medical degree (M.D./D.O. or equivalent). Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year) and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year. Possesses the ability to critically evaluate medical/scientific information. Excellent written an oral communication. Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast pace and changing environment. PREFERRED QUALIFICATIONS Documented work experience/knowledge of statistics Training and experience in infectious diseases and/or infection control in the hospital setting. Experience with investigational clinical trials. No pharmaceutical industry experience required. Work Location Assignment: On Premise (Marlow)
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we undertake a number of projects and activities designed to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated project coordinator to join our busy PMO and to work within our "Breath Biopsy Tests Programme". This is a pivotal role within a programme workstream. Working closely with a Principal Investigator (PI), you will take ownership for coordinating all of the various work packages and activities within a workstream. You will also work closely with the other Project Coordinators and the Programme Manager to ensure work is managed and coordinated across the whole programme. You will be expected to support the Study Lead and the Programme Manager throughout the full lifecycle of all project phases, including: Start Up - identify the customer/user and the scope of the project and work with the various stakeholders to define this in a project brief. Initiation - develop requirements and concepts, produce plans for the project schedule, resources, communication, risk and quality and develop a robust business case to form the foundation of the project. Execution - ensure that the work is managed with the focus on delivery. Understand the value and process behind good experimental design and verification and validation of results. Monitoring & Control - use a range of techniques and reporting to ensure schedule, budgets, risk, quality, scope, changes etc are under control. Closure - deliver the outputs, complete the documentation, learn the lessons! Due to the nature of research work, the projects and activities can change direction rapidly and frequently so, whilst good project management practice is a strong requirement for the role, so too is the ability to be flexible and to react positively to changing circumstances. The results of experiments undertaken in the programme will often dictate the next steps and so the whole team need to be agile and ready to revise project plans and activities accordingly. You should also expect to play a key role in the administration of Intellectual Property (IP) and Non-Disclosure Agreements (NDAs). In addition to this, you will be an active member of the PMO. This could include acting as project assurance for other projects, running or contributing to the programme of development seminars and deputising for more senior staff as required. Requirements The following competences form the core strength of the PMO. You are expected to have some knowledge of the competences and be able to demonstrate some evidence of applying some of them in uncomplicated situations: Leadership & professionalism - the ability to empower and inspire others to deliver successful projects and to act in a morally, legally and socially appropriate manner. Team management - the ability to select, motivate, develop and manage teams to achieve specified objectives and to resolve differences and conflicts between them. Stakeholder management - the ability to identify and effectively engage with all stakeholders, taking account of their levels of influence and particular interests. Planning - the ability to consolidate and document the fundamental components of a project and then prepare and maintain schedules for project activities and events. Financial management - the ability to develop and agree budgets for projects, and to control forecast and actual costs demonstrating commercial awareness. Quality management - the ability to ensure that the project outputs and processes through which they are delivered are meeting stakeholder requirements. Requirements management - the ability to capture, assess and justify stakeholders wants and needs to arrive at an agreed schedule of requirements. Risk & issue management - the ability to identify risks (threats and opportunities) and issues, assess them and plan and implement appropriate responses. Benefits realisation - the ability to manage the integration of the outputs of the project into business-as-usual in order to realise the business benefits. Governance - the ability to establish and maintain structures that define clear roles, responsibilities and accountabilities for governance and delivery of the project. Essential Requirements: Experience - you will have experience as a project coordinator / manager or in a similar role Knowledge - you will have some awareness of the regulatory issues surrounding clinical trials and research studies, e.g. ethics, data protection, etc Education - A degree in a life science discipline Communication - you will have excellent written and verbal communication skills and be comfortable leading meetings and delivering effective presentations. Information Technology - you will be competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA, MS Project, Confluence, etc. Desirable Requirements: Experience of working within an ISO 9001 Quality Management System A formal Project Management qualification (e.g. PRINCE2, MSP, APM, etc)
Sep 24, 2022
Full time
Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we undertake a number of projects and activities designed to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated project coordinator to join our busy PMO and to work within our "Breath Biopsy Tests Programme". This is a pivotal role within a programme workstream. Working closely with a Principal Investigator (PI), you will take ownership for coordinating all of the various work packages and activities within a workstream. You will also work closely with the other Project Coordinators and the Programme Manager to ensure work is managed and coordinated across the whole programme. You will be expected to support the Study Lead and the Programme Manager throughout the full lifecycle of all project phases, including: Start Up - identify the customer/user and the scope of the project and work with the various stakeholders to define this in a project brief. Initiation - develop requirements and concepts, produce plans for the project schedule, resources, communication, risk and quality and develop a robust business case to form the foundation of the project. Execution - ensure that the work is managed with the focus on delivery. Understand the value and process behind good experimental design and verification and validation of results. Monitoring & Control - use a range of techniques and reporting to ensure schedule, budgets, risk, quality, scope, changes etc are under control. Closure - deliver the outputs, complete the documentation, learn the lessons! Due to the nature of research work, the projects and activities can change direction rapidly and frequently so, whilst good project management practice is a strong requirement for the role, so too is the ability to be flexible and to react positively to changing circumstances. The results of experiments undertaken in the programme will often dictate the next steps and so the whole team need to be agile and ready to revise project plans and activities accordingly. You should also expect to play a key role in the administration of Intellectual Property (IP) and Non-Disclosure Agreements (NDAs). In addition to this, you will be an active member of the PMO. This could include acting as project assurance for other projects, running or contributing to the programme of development seminars and deputising for more senior staff as required. Requirements The following competences form the core strength of the PMO. You are expected to have some knowledge of the competences and be able to demonstrate some evidence of applying some of them in uncomplicated situations: Leadership & professionalism - the ability to empower and inspire others to deliver successful projects and to act in a morally, legally and socially appropriate manner. Team management - the ability to select, motivate, develop and manage teams to achieve specified objectives and to resolve differences and conflicts between them. Stakeholder management - the ability to identify and effectively engage with all stakeholders, taking account of their levels of influence and particular interests. Planning - the ability to consolidate and document the fundamental components of a project and then prepare and maintain schedules for project activities and events. Financial management - the ability to develop and agree budgets for projects, and to control forecast and actual costs demonstrating commercial awareness. Quality management - the ability to ensure that the project outputs and processes through which they are delivered are meeting stakeholder requirements. Requirements management - the ability to capture, assess and justify stakeholders wants and needs to arrive at an agreed schedule of requirements. Risk & issue management - the ability to identify risks (threats and opportunities) and issues, assess them and plan and implement appropriate responses. Benefits realisation - the ability to manage the integration of the outputs of the project into business-as-usual in order to realise the business benefits. Governance - the ability to establish and maintain structures that define clear roles, responsibilities and accountabilities for governance and delivery of the project. Essential Requirements: Experience - you will have experience as a project coordinator / manager or in a similar role Knowledge - you will have some awareness of the regulatory issues surrounding clinical trials and research studies, e.g. ethics, data protection, etc Education - A degree in a life science discipline Communication - you will have excellent written and verbal communication skills and be comfortable leading meetings and delivering effective presentations. Information Technology - you will be competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA, MS Project, Confluence, etc. Desirable Requirements: Experience of working within an ISO 9001 Quality Management System A formal Project Management qualification (e.g. PRINCE2, MSP, APM, etc)
Clinical Research Associate 2 / Senior CRA - (Regionalised) A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Wales £40,000 - £55,000 (DOE) My client, a large global organisation with a vast European presence are looking for an experienced CRA to join their business as a Senior CRA or CRA II. If you are looking for an opportunity to broaden your career, work on some truly fascinating studies in very niche therapeutic areas, or even just a genuine chance of ongoing career development then I am confident this could be the perfect organisation for you. The beauty of this client is that they focus on multiple therapy areas across all phases of the clinical trial spectrum which means no matter what your previous exposure has been there could be a perfect opportunity waiting for you. New medicine development is at the forefront of everything they do, this is a truly innovative business who are constantly looking for ways to change and better the future of the life sciences industry and as a result have been listed as one of the most admired companies to work for this year. If this isn't enough to make you want to apply then its also worth mentioning that this is a company who also take their corporate social responsibilities seriously, whether that be ways to prevent pollution and carbon emissions or more simply supporting causes that are important to their employees this is at the core of what they do. As an ARC your responsibilities will include: Coordinating Phase I-IV clinical trials Performing the full range of site visits: qualification, initiation, monitoring, motivational, audit support, and close out. Identifying and conducting feasibility assessments for proposed study sites in conjunction with the Project Team. Liaising with other appropriate departments to ensure the smooth running of the study Provide guidance and leadership to more junior CRAs (Senior CRA responsibility) Your previous experience should include: A degree in life science or related and experience of independent monitoring within clinical research, including good clinical knowledge and working understanding of GCP Regulations. In addition, previous experience within any other Clinical function would be highly advantageous. This position is home based anywhere across France and therefore flexibility to travel will be essential. To know more about this terrific company and to get a better feel for whether this position falls in line with your expectations, please speak to Paul Adam using the below contact information: (0)
Sep 24, 2022
Full time
Clinical Research Associate 2 / Senior CRA - (Regionalised) A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Wales £40,000 - £55,000 (DOE) My client, a large global organisation with a vast European presence are looking for an experienced CRA to join their business as a Senior CRA or CRA II. If you are looking for an opportunity to broaden your career, work on some truly fascinating studies in very niche therapeutic areas, or even just a genuine chance of ongoing career development then I am confident this could be the perfect organisation for you. The beauty of this client is that they focus on multiple therapy areas across all phases of the clinical trial spectrum which means no matter what your previous exposure has been there could be a perfect opportunity waiting for you. New medicine development is at the forefront of everything they do, this is a truly innovative business who are constantly looking for ways to change and better the future of the life sciences industry and as a result have been listed as one of the most admired companies to work for this year. If this isn't enough to make you want to apply then its also worth mentioning that this is a company who also take their corporate social responsibilities seriously, whether that be ways to prevent pollution and carbon emissions or more simply supporting causes that are important to their employees this is at the core of what they do. As an ARC your responsibilities will include: Coordinating Phase I-IV clinical trials Performing the full range of site visits: qualification, initiation, monitoring, motivational, audit support, and close out. Identifying and conducting feasibility assessments for proposed study sites in conjunction with the Project Team. Liaising with other appropriate departments to ensure the smooth running of the study Provide guidance and leadership to more junior CRAs (Senior CRA responsibility) Your previous experience should include: A degree in life science or related and experience of independent monitoring within clinical research, including good clinical knowledge and working understanding of GCP Regulations. In addition, previous experience within any other Clinical function would be highly advantageous. This position is home based anywhere across France and therefore flexibility to travel will be essential. To know more about this terrific company and to get a better feel for whether this position falls in line with your expectations, please speak to Paul Adam using the below contact information: (0)
Associate Director of Statistics - Top 5 Global Pharma - Greater London Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below. We are looking for an Associate Director in Statistics for a pharmaceutical company to be based in the UK. In this role you will provide lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence specialising in Oncology. This is an exciting and challenging role for a candidate with a strong interest in, and a deep understanding of the fundamentals of statistical methods and approaches and to build on these skills to explore and discover new ways to contribute with innovative statistical approaches in a challenging business context in the support of Oncology research. Responsibilities: The Statistics Associate Director: Experience in assisting with the heavy lifting, filing and documentation, for example, the execution from a given design onwards, statistics methods and documentation and all that follows Effectively Partnering with project teams (including medical and commercial leads, statistical programming, data management, medical writing, RWE, HTA, Biomarkers, Pharmacometrics, Bioinformatics) identifying appropriate clinical trial designs by proposing quantitative decision rules suitable to informing key study endpoints and their operational characteristics, by implementing flawless data analysis and reporting internally and for relevant publications. Demonstrates strong technical, analytical and interpersonal skills in project teams, internal forums and external meetings to establish and maintain methodologies constructively influencing decision making and clinical development strategy. Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates sophisticated data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies sophisticated statistical methodology in assigned projects, such as clinical trials, with demonstrated coordinated disease/scientific/functional area understanding and health authority acceptability. Do you have the experience, skills and education we are looking for? PhD. in Statistics or related field or MSc in Statistics with track record of relevant problem-solving demonstrating advanced data analytic expertise based on a solid foundation of statistical principles and an ability to positively influence and support decision-making at program level and in regulatory interactions through effective communication. Proficient use of relevant computational tools for study, experiment, or trial research objectives (e.g. SAS, R, Python or similar) in individual workstations and in validated computer systems. Demonstrates knowledge of pharmaceutical research and development appropriate for providing leadership and support to experimental design, modelling, analysis planning, analysis execution, interpretation and statistical communication ideally in Oncology. Is a leader in the optimization of study designs through scenario simulations and sample size calculations based on relevant assumptions in line with study or indication level objectives. Understands and aligns choice of methods with relevant regulatory guidance. Has a track record for proposing, implementing, evaluating and successfully communicating complex innovative statistical ideas and methods leading to improved business practices. Follows organization and company standard operating procedures as appropriate, including training and project time accounting and standard methodologies ensuring data integrity. Takes responsibility for and welcomes constructive feedback on the quality and timeliness of the assigned project deliverables, as assessed by partners such as the project team, the clinical trial team, and the Statistics Area Head. Serves as a role model to statisticians and other scientists as appropriate. Shares knowledge within and across functions to ensure integrated delivery across all phases of drug development. Supervises contractors or staff as required on a project basis. Mentors junior colleagues in techniques, processes, and responsibilities. Provides input into hiring decisions and ongoing evaluation of talent. Actively pursues robust cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations, consultants, researchers, investigators) to achieve results for project specific needs with focus on effective communication, efficiency, and productivity. Works cross-functionally to identify and problem solve when appropriate. What do you get in return? Working in a friendly group in exciting projects Excellent opportunities to develop and grow Home working flexibility Industry leading salary, annual bonus, and Long-Term Incentive Plan Extremely competitive benefits package What to do next : If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible. Not what you're looking for? Please contact Aimee Weston at to arrange a confidential discussion about potential opportunities.
Sep 23, 2022
Full time
Associate Director of Statistics - Top 5 Global Pharma - Greater London Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below. We are looking for an Associate Director in Statistics for a pharmaceutical company to be based in the UK. In this role you will provide lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence specialising in Oncology. This is an exciting and challenging role for a candidate with a strong interest in, and a deep understanding of the fundamentals of statistical methods and approaches and to build on these skills to explore and discover new ways to contribute with innovative statistical approaches in a challenging business context in the support of Oncology research. Responsibilities: The Statistics Associate Director: Experience in assisting with the heavy lifting, filing and documentation, for example, the execution from a given design onwards, statistics methods and documentation and all that follows Effectively Partnering with project teams (including medical and commercial leads, statistical programming, data management, medical writing, RWE, HTA, Biomarkers, Pharmacometrics, Bioinformatics) identifying appropriate clinical trial designs by proposing quantitative decision rules suitable to informing key study endpoints and their operational characteristics, by implementing flawless data analysis and reporting internally and for relevant publications. Demonstrates strong technical, analytical and interpersonal skills in project teams, internal forums and external meetings to establish and maintain methodologies constructively influencing decision making and clinical development strategy. Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates sophisticated data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies sophisticated statistical methodology in assigned projects, such as clinical trials, with demonstrated coordinated disease/scientific/functional area understanding and health authority acceptability. Do you have the experience, skills and education we are looking for? PhD. in Statistics or related field or MSc in Statistics with track record of relevant problem-solving demonstrating advanced data analytic expertise based on a solid foundation of statistical principles and an ability to positively influence and support decision-making at program level and in regulatory interactions through effective communication. Proficient use of relevant computational tools for study, experiment, or trial research objectives (e.g. SAS, R, Python or similar) in individual workstations and in validated computer systems. Demonstrates knowledge of pharmaceutical research and development appropriate for providing leadership and support to experimental design, modelling, analysis planning, analysis execution, interpretation and statistical communication ideally in Oncology. Is a leader in the optimization of study designs through scenario simulations and sample size calculations based on relevant assumptions in line with study or indication level objectives. Understands and aligns choice of methods with relevant regulatory guidance. Has a track record for proposing, implementing, evaluating and successfully communicating complex innovative statistical ideas and methods leading to improved business practices. Follows organization and company standard operating procedures as appropriate, including training and project time accounting and standard methodologies ensuring data integrity. Takes responsibility for and welcomes constructive feedback on the quality and timeliness of the assigned project deliverables, as assessed by partners such as the project team, the clinical trial team, and the Statistics Area Head. Serves as a role model to statisticians and other scientists as appropriate. Shares knowledge within and across functions to ensure integrated delivery across all phases of drug development. Supervises contractors or staff as required on a project basis. Mentors junior colleagues in techniques, processes, and responsibilities. Provides input into hiring decisions and ongoing evaluation of talent. Actively pursues robust cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations, consultants, researchers, investigators) to achieve results for project specific needs with focus on effective communication, efficiency, and productivity. Works cross-functionally to identify and problem solve when appropriate. What do you get in return? Working in a friendly group in exciting projects Excellent opportunities to develop and grow Home working flexibility Industry leading salary, annual bonus, and Long-Term Incentive Plan Extremely competitive benefits package What to do next : If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible. Not what you're looking for? Please contact Aimee Weston at to arrange a confidential discussion about potential opportunities.
Site Name: UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Zug House Posted Date: Sep The Global Medical Affairs Lead (GMAL) will be at the forefront of GSK's re-emergence in discovering and providing cutting edge Oncology treatments. The person taking on this role will work closely with their peers in Clinical Development, Clinical Research and Commercial to formulate and execute a world class Global Medical Affairs strategy immune-oncology (IO). This person will be directly responsible for leading the Dostarlimab program within the Breast and Gynecological Oncology (BGO) group. The strategic role is accountable for developing the strategy inclusive of scientific communication strategy, training plans, alliances, guideline strategy, investigator sponsored studies and areas of interest, Phase IIIb and IV evidence generation studies, including post-approval commitments and health outcomes studies. Working in close partnership with R&D, you will deliver the evidence needs for the assets and will be accountable for developing and delivering the Integrated Evidence Generation Plan (spanning late stage development and post launch market access support). You will engage in scientific exchange with external experts and will lead efforts to rebuild the GSK Oncology medical presence with our stakeholders. You will be a member of both the Medicines Development Team in R&D and the Medicines Commercialisation Team. You will act as the single voice of Medical Affairs for synthetic lethality, into R&D and Commercial. This is a highly visible, influential leadership role, requiring excellent networking, communication and influencing skills to work effectively in a highly matrixed environment. Key responsibilities: Safety and efficacy evaluation and optimization Gather medical insights from the field medical team, patient advocacy, in-country GSK experts, and key external stakeholders to inform and shape product strategy and to be accountable for the development of the integrated evidence strategy and plan (from Commit to Medicine Development - C2MD- onwards). Work in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy. Accountable for the execution of phase IIIb and IV studies, including post-approval commitments, if applicable. Evaluates local data needs for assets in partnership with relevant stakeholders locally (core countries). Responsible for asset strategy, Global alignment and differentiation plan for the asset Develops evidence plans (in partnership with R&D). Leads the global scientific engagement strategy for the asset and is an external speaker for GSK at scientific congresses or other company organised events. Seeks relevant scientific / medical insight from stakeholder groups. Lead the external engagement plan and develop strong relationships with external stakeholders. Lead and implement global scientific engagement program including development and maintenance of Scientific Platform and ensure medical governance. Accountability for the medical ABPI certification of launch materials and activities to ensure they are compliant with GSK SOPs and external industry standards. Responsible for Integrated Strategic Medical Plan for synthetic lethality assets BD and Due Diligence for synthetic lethality assets Application of Knowledge Leads and Embeds Medical Governance. Evaluates local data needs for assets in partnership with relevant stakeholders locally (core countries). Formulates strategies for the asset and develops evidence plans (in partnership with R&D). Execution of phase IIIB -IV studies, in addition to post-approval commitments, if applicable. Leads the global scientific engagement strategy for the asset. Seeks relevant scientific / medical insight from stakeholder groups, including governments. Problem Solving & Innovation Identifying gaps and opportunities from the complexity and volume of data emerging from the countries. Consolidating the information into one coherent strategy that is supported by key internal business stakeholders. Resolving issues with regulators/governments and negotiating appropriate needs and strategies to develop evidence for the asset. Ensuring appropriate interaction and exchange of scientific information in adherence with scientific engagement principles and standards, locally and globally. Interaction Interaction with external stakeholders (including governments). Discussing current and emerging treatment management issues, treatment evolution, guidelines, and health policies Discussing scientific issues related to clinical development, study design, data interpretation, study conclusions, and protocol recommendations Job involves interface with a very wide range of stakeholders internally and externally, and this requires a strong listening and communication skills, and collaborative teamworking. Impact Decision-making on strategic plans. Single voice of Medical to R&D and Commercial for the asset. Senior most Medical Affairs leader dedicated to the synthetic lethality Franchise. Medical Governance oversight to ensure focus on patient. Key external face of GSK for a medicine in development. Contributes synthetic lethality asset evaluation Candidate profile: MD, PharmD or PhD qualified with strong experience in oncology within IO therapies and/or gynecological oncology. Proven Medical Affairs leadership experience in country and above country roles. Experience with Pre-Launch activities. Oncology drug development experience. Demonstrable cross functional matrix leadership skills. Strong stance on compliance and awareness of local, regional and global regulations relating to the development and launch of Pharmaceutical products. Strong collaboration and partnering skills. Preferred: Board certified oncologist GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. ..... click apply for full job details
Sep 23, 2022
Full time
Site Name: UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Zug House Posted Date: Sep The Global Medical Affairs Lead (GMAL) will be at the forefront of GSK's re-emergence in discovering and providing cutting edge Oncology treatments. The person taking on this role will work closely with their peers in Clinical Development, Clinical Research and Commercial to formulate and execute a world class Global Medical Affairs strategy immune-oncology (IO). This person will be directly responsible for leading the Dostarlimab program within the Breast and Gynecological Oncology (BGO) group. The strategic role is accountable for developing the strategy inclusive of scientific communication strategy, training plans, alliances, guideline strategy, investigator sponsored studies and areas of interest, Phase IIIb and IV evidence generation studies, including post-approval commitments and health outcomes studies. Working in close partnership with R&D, you will deliver the evidence needs for the assets and will be accountable for developing and delivering the Integrated Evidence Generation Plan (spanning late stage development and post launch market access support). You will engage in scientific exchange with external experts and will lead efforts to rebuild the GSK Oncology medical presence with our stakeholders. You will be a member of both the Medicines Development Team in R&D and the Medicines Commercialisation Team. You will act as the single voice of Medical Affairs for synthetic lethality, into R&D and Commercial. This is a highly visible, influential leadership role, requiring excellent networking, communication and influencing skills to work effectively in a highly matrixed environment. Key responsibilities: Safety and efficacy evaluation and optimization Gather medical insights from the field medical team, patient advocacy, in-country GSK experts, and key external stakeholders to inform and shape product strategy and to be accountable for the development of the integrated evidence strategy and plan (from Commit to Medicine Development - C2MD- onwards). Work in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy. Accountable for the execution of phase IIIb and IV studies, including post-approval commitments, if applicable. Evaluates local data needs for assets in partnership with relevant stakeholders locally (core countries). Responsible for asset strategy, Global alignment and differentiation plan for the asset Develops evidence plans (in partnership with R&D). Leads the global scientific engagement strategy for the asset and is an external speaker for GSK at scientific congresses or other company organised events. Seeks relevant scientific / medical insight from stakeholder groups. Lead the external engagement plan and develop strong relationships with external stakeholders. Lead and implement global scientific engagement program including development and maintenance of Scientific Platform and ensure medical governance. Accountability for the medical ABPI certification of launch materials and activities to ensure they are compliant with GSK SOPs and external industry standards. Responsible for Integrated Strategic Medical Plan for synthetic lethality assets BD and Due Diligence for synthetic lethality assets Application of Knowledge Leads and Embeds Medical Governance. Evaluates local data needs for assets in partnership with relevant stakeholders locally (core countries). Formulates strategies for the asset and develops evidence plans (in partnership with R&D). Execution of phase IIIB -IV studies, in addition to post-approval commitments, if applicable. Leads the global scientific engagement strategy for the asset. Seeks relevant scientific / medical insight from stakeholder groups, including governments. Problem Solving & Innovation Identifying gaps and opportunities from the complexity and volume of data emerging from the countries. Consolidating the information into one coherent strategy that is supported by key internal business stakeholders. Resolving issues with regulators/governments and negotiating appropriate needs and strategies to develop evidence for the asset. Ensuring appropriate interaction and exchange of scientific information in adherence with scientific engagement principles and standards, locally and globally. Interaction Interaction with external stakeholders (including governments). Discussing current and emerging treatment management issues, treatment evolution, guidelines, and health policies Discussing scientific issues related to clinical development, study design, data interpretation, study conclusions, and protocol recommendations Job involves interface with a very wide range of stakeholders internally and externally, and this requires a strong listening and communication skills, and collaborative teamworking. Impact Decision-making on strategic plans. Single voice of Medical to R&D and Commercial for the asset. Senior most Medical Affairs leader dedicated to the synthetic lethality Franchise. Medical Governance oversight to ensure focus on patient. Key external face of GSK for a medicine in development. Contributes synthetic lethality asset evaluation Candidate profile: MD, PharmD or PhD qualified with strong experience in oncology within IO therapies and/or gynecological oncology. Proven Medical Affairs leadership experience in country and above country roles. Experience with Pre-Launch activities. Oncology drug development experience. Demonstrable cross functional matrix leadership skills. Strong stance on compliance and awareness of local, regional and global regulations relating to the development and launch of Pharmaceutical products. Strong collaboration and partnering skills. Preferred: Board certified oncologist GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. ..... click apply for full job details
Job title: Clinical Team Manager Location: UK based, fully remote Sponsor dedicated ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Responsibilities Working fully embedded within one of our global pharmaceutical clients, with the support of ICON right behind you, you ll be at the heart of our client s innovation. As a Clinical Team Manager you will be dedicated to one of our global pharmaceutical clients who aim to use science-based innovation to deliver better patient outcomes. They aim to lead in growing areas of healthcare. The Clinical Team Manager is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CTM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities. May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input Assess appropriateness of study for local environment Conducts country/site feasibility. Leads selection of sites within country; accountable for site performance. Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning. Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management. Accountable to manage recruitment into clinical studies in accordance to relevant country commitments including contingency planning. Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department. With oversight; Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials. Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally. Responsible for submitting or assisting with (in accordance with local regulations and our client's standard practice) the ethics committee/IRB submissions. In some cases, may also be accountable for Regulatory Authority submissions and approvals. Arranges accurate translations of key study documentation into local language as required. Provides support / develops and negotiates Clinical Trial Agreements (depending on our client's local practices) with the investigational sites, ensuring legal input where required. Ensures necessary supplies are available at sites and manages local supply inventory. Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed. Build close working relationships with key partners including local medical staff. Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings and local training. Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports. Accountable to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy. Escalates resourcing issues to ensure that in-country study activities are appropriately resourced. Ensures robust communication with sites, e.g. timely communication of protocol amendments. Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status. Ensures ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting). Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and written standards. Reviews, ensures completeness and maintains accuracy of Sponsor Study Records. Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement. Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills. Keep up to date with all the changes / required knowledge on ICH GCP, written standards and attending appropriate training sessions. Qualifications What do you need to have? Education: Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse Required skills 8 years of relevant experience Right to work in the UK Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job. Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements. Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners. Solid understanding of country local regulations, ICH-GCP guidelines and company written standards. Flexible and resilient with ability to evolve in changing and challenging environment. Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills. Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Sep 23, 2022
Full time
Job title: Clinical Team Manager Location: UK based, fully remote Sponsor dedicated ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Responsibilities Working fully embedded within one of our global pharmaceutical clients, with the support of ICON right behind you, you ll be at the heart of our client s innovation. As a Clinical Team Manager you will be dedicated to one of our global pharmaceutical clients who aim to use science-based innovation to deliver better patient outcomes. They aim to lead in growing areas of healthcare. The Clinical Team Manager is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CTM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities. May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input Assess appropriateness of study for local environment Conducts country/site feasibility. Leads selection of sites within country; accountable for site performance. Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning. Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management. Accountable to manage recruitment into clinical studies in accordance to relevant country commitments including contingency planning. Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department. With oversight; Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials. Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally. Responsible for submitting or assisting with (in accordance with local regulations and our client's standard practice) the ethics committee/IRB submissions. In some cases, may also be accountable for Regulatory Authority submissions and approvals. Arranges accurate translations of key study documentation into local language as required. Provides support / develops and negotiates Clinical Trial Agreements (depending on our client's local practices) with the investigational sites, ensuring legal input where required. Ensures necessary supplies are available at sites and manages local supply inventory. Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed. Build close working relationships with key partners including local medical staff. Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings and local training. Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports. Accountable to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy. Escalates resourcing issues to ensure that in-country study activities are appropriately resourced. Ensures robust communication with sites, e.g. timely communication of protocol amendments. Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status. Ensures ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting). Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and written standards. Reviews, ensures completeness and maintains accuracy of Sponsor Study Records. Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement. Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills. Keep up to date with all the changes / required knowledge on ICH GCP, written standards and attending appropriate training sessions. Qualifications What do you need to have? Education: Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse Required skills 8 years of relevant experience Right to work in the UK Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job. Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements. Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners. Solid understanding of country local regulations, ICH-GCP guidelines and company written standards. Flexible and resilient with ability to evolve in changing and challenging environment. Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills. Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. Principal Biostatistician Position Summary This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies. Responsibilities: • Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact. • Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design • Review project database structures, edit checks and data management coding conventions • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports • Statistical analysis, Interpretation of data and reporting of results. • Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports. • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission • Participates in presentations at client and investigator meetings. • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. • Ongoing coaching and mentorship of team members. Key Requirements: • M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry). • Experience with oncology is required • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas. • Excellent verbal and written communication skills as well as interpersonal and project management skills • Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must. • Experience leading a regulatory submission • Must be able to translate clients needs into statistical practice and educate clients in the use of statistics. Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Are you a current ICON Employee? Please click here to apply: link
Sep 23, 2022
Full time
At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. Principal Biostatistician Position Summary This position will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies. Responsibilities: • Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact. • Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design • Review project database structures, edit checks and data management coding conventions • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports • Statistical analysis, Interpretation of data and reporting of results. • Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports. • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission • Participates in presentations at client and investigator meetings. • Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. • Ongoing coaching and mentorship of team members. Key Requirements: • M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry). • Experience with oncology is required • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas. • Excellent verbal and written communication skills as well as interpersonal and project management skills • Excellent knowledge of a wide variety of principles, theories and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must. • Experience leading a regulatory submission • Must be able to translate clients needs into statistical practice and educate clients in the use of statistics. Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Are you a current ICON Employee? Please click here to apply: link
About You CSL Vifor is a world leader in Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. We are looking to appoint a UK and Ireland Medical Director to provide leadership to an established group of medical, quality, regulatory and safety professionals. You will have a strong and well-established track record of success in leading a full scope of medical activities for a UK and (ideally Ireland) local operating company. Sitting on the UK Senior Leadership Team and leading both office and field based medical operations. You will have management responsibility for local medical information/pharmacvigilance and safety, GxP and oversight of regulatory activities and UK Investigator Initiated Studies.. Critical to the success of this role is working in close partnership with the UK and Ireland commercial organisations to ensure both the development of in market brands and the effective launch of pipeline products in a compliant manner, promoting collaborative solutions in partnership with commercial counterparts. As we continue to innovate and grow this is an exceptional opportunity to work in a business which has a track record of bringing life improving medicines to market. Key Measures of Success Demonstrated an aligned collaboration within senior leadership team and cross-functional stakeholders to meet corporate goals Respected member of the country leadership team Respected and consulted by global and medical teams from other countries for local medical expertise Medical plan implemented to meet medical goals aligned with cross functional objectives Delivered effective medical internal and external engagement initiatives Execution of local data generation activities and reliable support for global activities and Investigator-Initiated Studies (IIS) Demonstrated effectiveness of the field medical team measured by appropriate metrics that are defined by Global Field Medical Excellence in alignment with Country Medical Director and/ or Head FIELD MEDICAL ADVISERS Compliance with local laws, regulations & codes, and CSL Vifor processes Main Accountabilities Leads Medical team to accomplish their objectives in a compliant manner and following company values and strategies Strong member of the country leadership team, shaping the development of the local strategy via therapeutic area clinical knowledge and insight from HCP interactions Ownership of local medical governance and is ultimate decision maker for local Medical department, incl. escalated issues Development and compliant implementation of the annual country medical plan, ensuring alignment with the cross functional brand and country strategic imperatives as well as Global medical plans Closely collaborate with colleagues in the development and implementation of the local brand strategy Establish effective clinical engagement with medical / scientific associations, external medical experts, and other external stakeholders (e.g. patient advocacy groups, payer organizations) Oversees the local data gap analysis and local data generation plan Oversees the local data generation activities and research grants Management of country Medical budget Compliance of Medical deliverables with local laws, regulations & codes, and company processes Compliance of local Medical processes with internal global processes and guidance Approval of local materials and activities Registered signatory for country promotional and medical materials Responsible Local Function per local ABAC guidelines Medical team is adequately trained and required trainings are in place Ultimate decision maker for Compliance All drug safety requirements met (Deputy) Local QPPV/ Local Drug Safety Responsible Qualifications and Requirements Minimum Requirements Medical Doctor / Physician with full GMC registration. Well established expertise in the ABPI (must be an existing ABPI final signatory) Minimum of 7 years' experience with pharma industry in Medical Affairs including at UK / Ireland affiliate level Proven experience in people management in Medical Affairs Experience with local health care compliance topics Proven relationship building skills with internal and external stakeholders Working knowledge of commercialization and business practices, as well as budgeting experience Working knowledge in Regulatory Affairs, Pharmacovigilance and Quality Management Preferred Requirements Medical specialisation and/ or clinical / research experience in Internal Medicine, Nephrology or Cardiology Significant experience with pharma industry in Medical Affairs, Clinical Development and/ or Drug Safety/ Regulatory Affairs at affiliate level and regional or global headquarters Experience with non-interventional study management and conduct Publication track record About Us
Sep 23, 2022
Full time
About You CSL Vifor is a world leader in Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. We are looking to appoint a UK and Ireland Medical Director to provide leadership to an established group of medical, quality, regulatory and safety professionals. You will have a strong and well-established track record of success in leading a full scope of medical activities for a UK and (ideally Ireland) local operating company. Sitting on the UK Senior Leadership Team and leading both office and field based medical operations. You will have management responsibility for local medical information/pharmacvigilance and safety, GxP and oversight of regulatory activities and UK Investigator Initiated Studies.. Critical to the success of this role is working in close partnership with the UK and Ireland commercial organisations to ensure both the development of in market brands and the effective launch of pipeline products in a compliant manner, promoting collaborative solutions in partnership with commercial counterparts. As we continue to innovate and grow this is an exceptional opportunity to work in a business which has a track record of bringing life improving medicines to market. Key Measures of Success Demonstrated an aligned collaboration within senior leadership team and cross-functional stakeholders to meet corporate goals Respected member of the country leadership team Respected and consulted by global and medical teams from other countries for local medical expertise Medical plan implemented to meet medical goals aligned with cross functional objectives Delivered effective medical internal and external engagement initiatives Execution of local data generation activities and reliable support for global activities and Investigator-Initiated Studies (IIS) Demonstrated effectiveness of the field medical team measured by appropriate metrics that are defined by Global Field Medical Excellence in alignment with Country Medical Director and/ or Head FIELD MEDICAL ADVISERS Compliance with local laws, regulations & codes, and CSL Vifor processes Main Accountabilities Leads Medical team to accomplish their objectives in a compliant manner and following company values and strategies Strong member of the country leadership team, shaping the development of the local strategy via therapeutic area clinical knowledge and insight from HCP interactions Ownership of local medical governance and is ultimate decision maker for local Medical department, incl. escalated issues Development and compliant implementation of the annual country medical plan, ensuring alignment with the cross functional brand and country strategic imperatives as well as Global medical plans Closely collaborate with colleagues in the development and implementation of the local brand strategy Establish effective clinical engagement with medical / scientific associations, external medical experts, and other external stakeholders (e.g. patient advocacy groups, payer organizations) Oversees the local data gap analysis and local data generation plan Oversees the local data generation activities and research grants Management of country Medical budget Compliance of Medical deliverables with local laws, regulations & codes, and company processes Compliance of local Medical processes with internal global processes and guidance Approval of local materials and activities Registered signatory for country promotional and medical materials Responsible Local Function per local ABAC guidelines Medical team is adequately trained and required trainings are in place Ultimate decision maker for Compliance All drug safety requirements met (Deputy) Local QPPV/ Local Drug Safety Responsible Qualifications and Requirements Minimum Requirements Medical Doctor / Physician with full GMC registration. Well established expertise in the ABPI (must be an existing ABPI final signatory) Minimum of 7 years' experience with pharma industry in Medical Affairs including at UK / Ireland affiliate level Proven experience in people management in Medical Affairs Experience with local health care compliance topics Proven relationship building skills with internal and external stakeholders Working knowledge of commercialization and business practices, as well as budgeting experience Working knowledge in Regulatory Affairs, Pharmacovigilance and Quality Management Preferred Requirements Medical specialisation and/ or clinical / research experience in Internal Medicine, Nephrology or Cardiology Significant experience with pharma industry in Medical Affairs, Clinical Development and/ or Drug Safety/ Regulatory Affairs at affiliate level and regional or global headquarters Experience with non-interventional study management and conduct Publication track record About Us