mRNA COVID-19 Vaccine Development Leader (VDL)
The CureVac-GSK COVID-19 collaboration was announced in February 2021 to jointly develop next-generation mRNA vaccines for COVID-19 to address multiple emerging variants in one vaccine. This work aims to offer broader protection against various SARS-CoV2 variants and enable a quick response to new variants potentially appearing in the future. The optimized mRNA backbone used in this collaboration also has the potential for a multivalent or combination approach to address multiple respiratory pathogens in one vaccine, such as COVID-19 and Influenza. The mRNA COVID-19 candidate vaccine is currently in Phase 1, and the results are expected later this year. The VDL role is highly strategic to advance the first mRNA vaccine for GSK and will lead the end-to-end development of the program in collaboration with the Curevac team. The VDL (Vaccine Development Leader) Role
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 VCL (accountable from approval in first major market).
- In addition to the overall leadership role, the VDL should provide key support to the VCT post-approval 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
- 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.
- 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.
The qualifications and experience required for the Vaccines Development Lead role include:
- Medical Degree with experience in Vaccines research
- Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs.
- Broad drug development expertise and experience
- Considerable pharmaceutical industry experience
- Prior significant experience in leading successful development and registration of Vaccines
- Deep experience in product development, 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
- Ability to work collaboratively and successfully across functions -research, commercial, regulatory, global Vaccine supply, legal, regions etc.
- Ability to build relationships and create authentic alignment while leading high performing teams in a collaborative and purposeful manner to achieve defined objectives
- Business acumen and experience of managing a sizable P&L which has organizational impact. Experience of building budgets and then leading the strategic and budget planning process
- Track record of leading with high operational complexity. Including global, geographically dispersed teams, multi-disciplinary structures with high accountability, minimal authority, and multiple lines of reporting
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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