Merck Gruppe - MSD Sharp & Dohme
Job Description Due to internal promotion, we are recruiting for a Head of HTA & OR (Director level) to be based in our UK Headquarters in Moorgate, London. Please note, our company operates a hybrid working model and this role will require some travel across the UK/EU/US. Our company's Health Technology Assessment & Outcomes Research team is one of the largest in the UK. This leadership role within the organisation, offers significant development opportunities as well as making a meaningful difference to people's lives by enabling national access to the company's novel medicines and vaccines. Our UK HTA team is responsible for submissions to NICE, SMC, AWMSG and the JCVI, as well as supporting the Irish affiliate with NCPE submissions. The team support regional and local access through the development of tools and resources for payer customers. We also lead and support appropriate evidence generation activities. The team is made up of health economists, evidence-based medicine managers and real-world evidence generation experts. The Head of HTA & OR is a critical externally and internally oriented role which plays a significant part in the ongoing success of our company in the UK. The person in this role will report to the Executive Director of Value, Access & Devolved Nations (VAD) and work closely with all local, regional and global departments to enable national access for our products and the support of regional and local access initiatives. They will be accountable for the 2nd line management and direction of the HTA&OR function (Team of 25 people) What you will do: Lead and Develop a group of Team Leads, Specialists (Health Economists and Evidence Based Managers) and Associates to develop and deliver the necessary materials in order to enable national access for our products. Direct on developing and delivering the strategy to maximise access for patients to our products at National, Regional and Local level, with the aim of demonstrating value at the same time as preserving value. Direct the development of UK Data Strategy, including the identification of the need for, and subsequent development of, Real World Evidence (RWE) and collaborating with medical colleagues on local data generation Partner with and engage stakeholders across the UK Leadership Team, Business Units and wider cross functional teams to ensure alignment with the UK strategy (including Medical, Legal and Commercial Business Units) Develop and maintain relationships with key stakeholders in the wider business, including Global Market Access (GMAx), Centre for Observational and Real-World Evidence (CORE) and other Global / Regional teams, including participation in the CORE Extended Leadership Team. Ensure that the needs of the UK business from an access perspective (economic models, clinical data synthesis, RWE) are clearly realised at National, Regional and Global levels and be responsible for them being met. Develop and maintain relationships with key stakeholders in NICE, SMC, AWMSG, NCPE and NHS Represent our UK company at relevant work-streams/groups in ABPI. Ensure provision of appropriate support to new products and business development. Integral part of the VAD Leadership Team that will develop, co-create and direct the business and people strategy Education, Experience required: Graduate Post graduate qualification - Health Economics, HTA & OR methods Significant experience within industry and expert within HTA & OR Thorough understanding of NHS/UK External environment Proficient knowledge of our company's portfolio Expert financial and commercial acumen Demonstrable, senior level people management / leadership, preferably second line management experience including - budgeting, planning and business processes Competencies/Skills required: Outstanding customer insight, good relationships with national payers and reimbursement agencies and key regional and Global partners, who can motivate and direct teams to deliver access A role which requires a willingness and ability to both develop strategy and deliver operationally. Customer Insight and Understanding; proven ability to develop meaningful customer relations (external and internal) to deliver on business objectives; takes an 'outside-in' approach Strategic Thinking; able to define, convey and execute on a strategic plan Programme/project Management; the ability to develop, direct and execute a robust approach to managing complex and diverse projects across multiple stakeholders and topics Strategic Consulting skills; the ability to work with clients to appreciate/diagnose issues/opportunities and agree on a realistic plan to deliver on objectives Leadership and People Management; Delivers on objectives through motivating others and setting an engaging, achievable vision. Capitalises on others' strengths whilst providing focused support for further development Business Acumen; works closely with business management to surface issues and test the status quo. Facilitates discussion & designs and implements processes to ensure problems and opportunities are overcome and fully exploited Problem Solving; Takes a methodical and robust approach to problem solving Adaptability: Shows high levels of energy and activity, creates a team culture. Positively embraces change and operates effectivelyin continually changing environment. Adapts willing and quickly to different tests and situations Closing date: 9th April 2024 Your role at our company is integral to helping the UK patients access novel treatments and vaccines. At our company, we're inventing for life. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Requisition ID:R280117
Job Description Due to internal promotion, we are recruiting for a Head of HTA & OR (Director level) to be based in our UK Headquarters in Moorgate, London. Please note, our company operates a hybrid working model and this role will require some travel across the UK/EU/US. Our company's Health Technology Assessment & Outcomes Research team is one of the largest in the UK. This leadership role within the organisation, offers significant development opportunities as well as making a meaningful difference to people's lives by enabling national access to the company's novel medicines and vaccines. Our UK HTA team is responsible for submissions to NICE, SMC, AWMSG and the JCVI, as well as supporting the Irish affiliate with NCPE submissions. The team support regional and local access through the development of tools and resources for payer customers. We also lead and support appropriate evidence generation activities. The team is made up of health economists, evidence-based medicine managers and real-world evidence generation experts. The Head of HTA & OR is a critical externally and internally oriented role which plays a significant part in the ongoing success of our company in the UK. The person in this role will report to the Executive Director of Value, Access & Devolved Nations (VAD) and work closely with all local, regional and global departments to enable national access for our products and the support of regional and local access initiatives. They will be accountable for the 2nd line management and direction of the HTA&OR function (Team of 25 people) What you will do: Lead and Develop a group of Team Leads, Specialists (Health Economists and Evidence Based Managers) and Associates to develop and deliver the necessary materials in order to enable national access for our products. Direct on developing and delivering the strategy to maximise access for patients to our products at National, Regional and Local level, with the aim of demonstrating value at the same time as preserving value. Direct the development of UK Data Strategy, including the identification of the need for, and subsequent development of, Real World Evidence (RWE) and collaborating with medical colleagues on local data generation Partner with and engage stakeholders across the UK Leadership Team, Business Units and wider cross functional teams to ensure alignment with the UK strategy (including Medical, Legal and Commercial Business Units) Develop and maintain relationships with key stakeholders in the wider business, including Global Market Access (GMAx), Centre for Observational and Real-World Evidence (CORE) and other Global / Regional teams, including participation in the CORE Extended Leadership Team. Ensure that the needs of the UK business from an access perspective (economic models, clinical data synthesis, RWE) are clearly realised at National, Regional and Global levels and be responsible for them being met. Develop and maintain relationships with key stakeholders in NICE, SMC, AWMSG, NCPE and NHS Represent our UK company at relevant work-streams/groups in ABPI. Ensure provision of appropriate support to new products and business development. Integral part of the VAD Leadership Team that will develop, co-create and direct the business and people strategy Education, Experience required: Graduate Post graduate qualification - Health Economics, HTA & OR methods Significant experience within industry and expert within HTA & OR Thorough understanding of NHS/UK External environment Proficient knowledge of our company's portfolio Expert financial and commercial acumen Demonstrable, senior level people management / leadership, preferably second line management experience including - budgeting, planning and business processes Competencies/Skills required: Outstanding customer insight, good relationships with national payers and reimbursement agencies and key regional and Global partners, who can motivate and direct teams to deliver access A role which requires a willingness and ability to both develop strategy and deliver operationally. Customer Insight and Understanding; proven ability to develop meaningful customer relations (external and internal) to deliver on business objectives; takes an 'outside-in' approach Strategic Thinking; able to define, convey and execute on a strategic plan Programme/project Management; the ability to develop, direct and execute a robust approach to managing complex and diverse projects across multiple stakeholders and topics Strategic Consulting skills; the ability to work with clients to appreciate/diagnose issues/opportunities and agree on a realistic plan to deliver on objectives Leadership and People Management; Delivers on objectives through motivating others and setting an engaging, achievable vision. Capitalises on others' strengths whilst providing focused support for further development Business Acumen; works closely with business management to surface issues and test the status quo. Facilitates discussion & designs and implements processes to ensure problems and opportunities are overcome and fully exploited Problem Solving; Takes a methodical and robust approach to problem solving Adaptability: Shows high levels of energy and activity, creates a team culture. Positively embraces change and operates effectivelyin continually changing environment. Adapts willing and quickly to different tests and situations Closing date: 9th April 2024 Your role at our company is integral to helping the UK patients access novel treatments and vaccines. At our company, we're inventing for life. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Requisition ID:R280117
GlaxoSmithKline
Brentford, Middlesex
Site Name: Belgium-Rixensart, GSK House, Rockville Vaccines Posted Date: Sep Vaccine Development Leader The core purpose of the VDL is to strategically lead the optimal global development of a Vaccine, acting as the single point of accountability for the Vaccine from C2P1/2 to approval in first major market, but substantially contributing and influencing from C2C to post-launch life-cycle management, to ultimately deliver differentiated vaccines of value. By working with the various stakeholders across R&D and Pharma, the VDL defines the strategic vision and operational plan for the vaccine, aligning it with the overall organizational strategy. The VDL creates and leads the matrix Vaccine Development Team (VDT), which has responsibility for representing all the various R&D and commercial disciplines required to optimally deliver the development of the Vaccine (including clinical development, statistics, clinical operations, medical affairs, safety, regulatory, commercial and technical development and manufacturing, amongst others). VDL's accountability and key responsibilities include but are not limited to: Act as a single point of accountability in GSK for all aspects of a vaccine in development globally from C2P1 to approval in first major markets. Works closely with the DPL (Discovery Project Leader) and VCL (Vaccines Commercialization Leader) to ensure a smooth transition between the DPL (accountable from Target to Candidate Selection) to VDL (accountable from Phase 1 to approval in first major market) and from VDL to MCL (accountable from approval in first major market). In addition to the overall leadership role, the VDL should provide key support to the VCT postapproval in first major markets ensuring that the VDT provide optimal support to both registration and LCM. Selects members of the Vaccines Development Team (VDT), in consultation with the line leaders, and leads this multi-disciplinary matrix team; supports differentiated development for team members; owns the performance of VDT and partners with line managers to drive performance Energizes and motivates the VDT to drive performance Establishes a compelling vision for the vaccine; positions the vaccine within the R&D strategy taking the competitive landscape into account; Translate GSK's strategy into asset strategy and actionable plans for multiple areas or functions. Delivers differentiated vaccines of value for patients, stakeholders and markets, through an evidence package that supports regulatory approval, market access, and product life cycle. Delivers the Vaccine Development Strategy that is aligned with the R&D disease strategy, as well as the asset Vaccine Vision and Vaccine Profile. Prioritizes and maximizes the asset's portfolio options including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the Vaccine, and identify clear inflection points Embeds core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy Identifies and aligns resources (people and financial), team objectives and strategies behind the vision to ensure successful project completion Proactively identifies unmet medical needs that could be addressed through line extensions Enhances patient focus by incorporating the voice of the patient into development plans. Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders Collaborates with other stakeholders but in particular DPLs and other VDLs to create strategies that support organizational vision; shares optimal ways of working and knowledge Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science Prioritizes and manages asset portfolio options to meet budget constraints. Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices. Model Values and Leadership Expectations internally and externally Asset single point of contact and spokesperson to senior management and senior boards (e.g., Chief Scientific Officer, Head of Development, Chief Medical Officer, President of Pharma, Development Review Board and Portfolio Investment Board) and other relevant internal governance committees and external Advisory Committees as needed. Increases visibility amongst the external communities (physicians, regulators, patients, payers), to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK. VDL serves as the single accountable decision maker to resolve disputes among the VDT. The VDL should discuss any team misalignment/disputes with the Head of Development prior to rending a final decision. VDL is accountable for delivering and managing the asset resourcing plan. In addition, the VDL is accountable for managing the asset budget to the agreed variance. VDL is accountable for developing an ongoing patent strategy for the asset VDL's Drivers: You are a talented and experienced leader motivated by the desire to make a difference in patients' lives. You are excited by challenging goals and positively impacting the progression of Vaccines of value to patients that provide the adequate return to the business. You have a proven ability to think and plan uniquely and strategically, to work with members of other functions within a matrix environment. You are Intrigued by innovation, creativity and new opportunities to learn You are energized by delivering high standards through collaboration and motivating others across the organization You are passionate about developing others into future leaders You are committed to maintaining the highest compliance standards Additional Responsibilities Scientific Engagement Accountable for global oversight, coordination, and approval of scientific engagement activities preauthorization. Secures advice to inform the development of products of value, for the benefit of patients and consumers. Identifies and engages the external community appropriately in robust scientific dialogue that generates insight and advances scientific and medical understanding. Ensures timely and appropriate interaction and exchange of information between GSK and external communities (e.g., patients, physicians, payers, regulators), in strict adherence with GSK Policies, and GSK Global Scientific Engagement Principles and Standards. Ensures balanced and robust scientific communications in all formats. Lifecycle Management Proactively identifies unmet needs that could be addressed through line extensions e.g. novel indications, combinations or formulations, or the provision of enhanced services. Anticipates the changing healthcare, regulatory & competitive environment throughout the product lifespan; defines and delivers innovative strategies and plans to inform evidence-based prescribing/ usage within this environment e.g. new comparator or real-world efficacy data. Understands the impact of new data on the value/positioning of products in guidelines/formularies. Business Development Partners with Business Development to facilitate diligence reviews, product positioning and/or alternative business strategies (e.g., public private partnerships, co-development) and internal review and decision-making processes in line with GSK governance procedures as well as use of appropriate alliance management mechanisms to ensure successful business transactions and relationships. WHY YOU? Basic qualifications The qualifications and experience required for the Vaccines Development Lead role include: Advanced degree such as PhD, MD or equivalent is highly preferable. Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs. Must demonstrate extensive broad drug development expertise and experience Considerable pharmaceutical industry experience is required Prior significant experience in leading successful development and registration of Vaccines is highly preferred Deep experience in product development and/or commercial, especially in late phase development (from PoC onwards), clinical trial management with significant operational complexity, post-approval studies, regulatory and manufacturing compliance Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills. Understands the entirety of R&D across the development/commercial life cycle to allow impact across all functions: discovery, late-stage development, regulatory, manufacturing and commercial. Track record of success working in highly complex, matrixed, global, and multi-disciplinary organization with high accountability, minimal authority, and multiple lines of reporting Experience working with regulators and regulatory requirements including an understanding of the legal and government frameworks within and across global geographies. Strong people management, leadership and motivational skills In-depth experience creating the strategy for pre- and post-marketing studies, and driving the lifecycle process..... click apply for full job details
Site Name: Belgium-Rixensart, GSK House, Rockville Vaccines Posted Date: Sep Vaccine Development Leader The core purpose of the VDL is to strategically lead the optimal global development of a Vaccine, acting as the single point of accountability for the Vaccine from C2P1/2 to approval in first major market, but substantially contributing and influencing from C2C to post-launch life-cycle management, to ultimately deliver differentiated vaccines of value. By working with the various stakeholders across R&D and Pharma, the VDL defines the strategic vision and operational plan for the vaccine, aligning it with the overall organizational strategy. The VDL creates and leads the matrix Vaccine Development Team (VDT), which has responsibility for representing all the various R&D and commercial disciplines required to optimally deliver the development of the Vaccine (including clinical development, statistics, clinical operations, medical affairs, safety, regulatory, commercial and technical development and manufacturing, amongst others). VDL's accountability and key responsibilities include but are not limited to: Act as a single point of accountability in GSK for all aspects of a vaccine in development globally from C2P1 to approval in first major markets. Works closely with the DPL (Discovery Project Leader) and VCL (Vaccines Commercialization Leader) to ensure a smooth transition between the DPL (accountable from Target to Candidate Selection) to VDL (accountable from Phase 1 to approval in first major market) and from VDL to MCL (accountable from approval in first major market). In addition to the overall leadership role, the VDL should provide key support to the VCT postapproval in first major markets ensuring that the VDT provide optimal support to both registration and LCM. Selects members of the Vaccines Development Team (VDT), in consultation with the line leaders, and leads this multi-disciplinary matrix team; supports differentiated development for team members; owns the performance of VDT and partners with line managers to drive performance Energizes and motivates the VDT to drive performance Establishes a compelling vision for the vaccine; positions the vaccine within the R&D strategy taking the competitive landscape into account; Translate GSK's strategy into asset strategy and actionable plans for multiple areas or functions. Delivers differentiated vaccines of value for patients, stakeholders and markets, through an evidence package that supports regulatory approval, market access, and product life cycle. Delivers the Vaccine Development Strategy that is aligned with the R&D disease strategy, as well as the asset Vaccine Vision and Vaccine Profile. Prioritizes and maximizes the asset's portfolio options including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the Vaccine, and identify clear inflection points Embeds core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy Identifies and aligns resources (people and financial), team objectives and strategies behind the vision to ensure successful project completion Proactively identifies unmet medical needs that could be addressed through line extensions Enhances patient focus by incorporating the voice of the patient into development plans. Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders Collaborates with other stakeholders but in particular DPLs and other VDLs to create strategies that support organizational vision; shares optimal ways of working and knowledge Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science Prioritizes and manages asset portfolio options to meet budget constraints. Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices. Model Values and Leadership Expectations internally and externally Asset single point of contact and spokesperson to senior management and senior boards (e.g., Chief Scientific Officer, Head of Development, Chief Medical Officer, President of Pharma, Development Review Board and Portfolio Investment Board) and other relevant internal governance committees and external Advisory Committees as needed. Increases visibility amongst the external communities (physicians, regulators, patients, payers), to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK. VDL serves as the single accountable decision maker to resolve disputes among the VDT. The VDL should discuss any team misalignment/disputes with the Head of Development prior to rending a final decision. VDL is accountable for delivering and managing the asset resourcing plan. In addition, the VDL is accountable for managing the asset budget to the agreed variance. VDL is accountable for developing an ongoing patent strategy for the asset VDL's Drivers: You are a talented and experienced leader motivated by the desire to make a difference in patients' lives. You are excited by challenging goals and positively impacting the progression of Vaccines of value to patients that provide the adequate return to the business. You have a proven ability to think and plan uniquely and strategically, to work with members of other functions within a matrix environment. You are Intrigued by innovation, creativity and new opportunities to learn You are energized by delivering high standards through collaboration and motivating others across the organization You are passionate about developing others into future leaders You are committed to maintaining the highest compliance standards Additional Responsibilities Scientific Engagement Accountable for global oversight, coordination, and approval of scientific engagement activities preauthorization. Secures advice to inform the development of products of value, for the benefit of patients and consumers. Identifies and engages the external community appropriately in robust scientific dialogue that generates insight and advances scientific and medical understanding. Ensures timely and appropriate interaction and exchange of information between GSK and external communities (e.g., patients, physicians, payers, regulators), in strict adherence with GSK Policies, and GSK Global Scientific Engagement Principles and Standards. Ensures balanced and robust scientific communications in all formats. Lifecycle Management Proactively identifies unmet needs that could be addressed through line extensions e.g. novel indications, combinations or formulations, or the provision of enhanced services. Anticipates the changing healthcare, regulatory & competitive environment throughout the product lifespan; defines and delivers innovative strategies and plans to inform evidence-based prescribing/ usage within this environment e.g. new comparator or real-world efficacy data. Understands the impact of new data on the value/positioning of products in guidelines/formularies. Business Development Partners with Business Development to facilitate diligence reviews, product positioning and/or alternative business strategies (e.g., public private partnerships, co-development) and internal review and decision-making processes in line with GSK governance procedures as well as use of appropriate alliance management mechanisms to ensure successful business transactions and relationships. WHY YOU? Basic qualifications The qualifications and experience required for the Vaccines Development Lead role include: Advanced degree such as PhD, MD or equivalent is highly preferable. Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs. Must demonstrate extensive broad drug development expertise and experience Considerable pharmaceutical industry experience is required Prior significant experience in leading successful development and registration of Vaccines is highly preferred Deep experience in product development and/or commercial, especially in late phase development (from PoC onwards), clinical trial management with significant operational complexity, post-approval studies, regulatory and manufacturing compliance Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills. Understands the entirety of R&D across the development/commercial life cycle to allow impact across all functions: discovery, late-stage development, regulatory, manufacturing and commercial. Track record of success working in highly complex, matrixed, global, and multi-disciplinary organization with high accountability, minimal authority, and multiple lines of reporting Experience working with regulators and regulatory requirements including an understanding of the legal and government frameworks within and across global geographies. Strong people management, leadership and motivational skills In-depth experience creating the strategy for pre- and post-marketing studies, and driving the lifecycle process..... click apply for full job details