Global Medical Affairs Lead, mRNA Covid

GlaxoSmithKline and CureVac's collaboration, building on our existing relationship, is focused to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.

Job Purpose

Provide global medical affairs leadership for next generation mRNA Covid vaccines in development ensuring consolidated, strategic medical input into R&D and commercialisation strategies. Drives the integration of insights from HCPs, patients, and the health care landscape into the asset profile in alignment with the global medical accountabilities as per the GSK integrated asset operating model.

Collaborative working with diverse business partners across R&D, commercial, value evidence, and regional/priority Local Operating Companies (LOCs) medical teams will be critical to ensure optimal evidence generation strategies are in place for successful registration, access, and overall launch readiness for assigned asset in early pipeline.

Key Responsibilities

• Provides global medical affairs leadership for the next generation of mRNA Covid vaccines in development, providing strategic medical insights into R&D and commercialization strategies.
• Responsible for strategic alignment with clinical development and central and regional partner functions, to develop and optimize the evidence generation plans in support of the scientific value proposition of assigned assets and aligns resource needs.
• Ensure that patient and customer's unmet medical needs and insights are captured and incorporated appropriately into the functional plans (e.g., Medical Affairs, Epidemiology, Health Outcomes, etc.) including appropriate engagement of external experts/scientific community
• Participate and develop the medical strategy within the Vaccine Development Team (VDT) and joint project team in alignment with the GMPL.
• Build the Medical evidence generation plan including key areas, geographic footprint, and an overall framework/guidance for evidence generation activities.
• Accountable for setting up and leading early GMAT and provide appropriate representation of assigned assets at governance boards.
• Accountable for creation and execution of the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for assigned asset(s)/ indication(s).
• Provides medical thought leadership and therapy area expertise to strategic portfolio discussions including anticipated changes in disease landscape, treatment paradigm and evolution of Policy/Payor scenarios in key LOCs to optimise data generation and life-cycle management plans globally.
• Drives excellence in scientific engagement with key stakeholders (HCPs, Patients, Payers and Regulators) to gather medical insights and build a deep understanding of customer needs to inform and shape the portfolio's development programme. Provides scientific insights to validate asset and recommendation assumptions during the technical and commercial review process.
• Reviews local GSK-sponsored and ISS proposals from Key LOCs to assess their scientific merit and strategic need, liaising with R&D technical experts.
• Develops and reviews publications / abstracts/ posters related to the product, key competitors and relevant disease area(s) and accountable for the Data Dissemination Plan (DDP)
• Responsible for ensuring plans and activities are implemented in a manner that is compliant with Scientific Engagement principles, GSK's Code of Practice and GSK values.
• Effective management of medical budget (MAP and IEP) for assigned assets
• Provides direction, support and guidance to SMM and MM
• Ensures that all communications are scientifically accurate, balanced, remain aligned with product strategy, and compliant to applicable laws and regulations.

Required qualifications and previous experience:

• Medical Doctor with specialty in infectious diseases. Will also consider a PharmD or PhD.
• Strong medical affairs experience at local, regional and global level.
• Knowledge and understanding of the development process from asset inception, early and late-stage development, launch and lifecycle management. Robust understanding of GCP regulatory/ market access and reimbursement requirements.
• Must be able to clearly demonstrate a thorough understanding of external healthcare environment including all external stakeholders.
• Must be able to demonstrate understanding of medical affairs accountabilities for evidence generation, external engagement and internal advice; direct experience preferred.
• Demonstrate disease area expertise and appropriate medical and/or clinical experience.
• Deep knowledge of external healthcare environment.
• Strong analytical skills to be able to assess and interpret scientific data and ability to input into the design and implementation of clinical studies (Phase 1, 2 & 3b /4 studies).
• Developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
• Demonstrated ability in engaging, building and sustaining a broad and strong external (expert) network.
• Strong understanding and track record of adherence to the ethical, regulatory, compliance and legal framework which underpins all interactions with the external environment.
• Experienced communicator on scientific/medical topics in fora of different audiences, including advisory boards, public panel discussion, interaction with policy makers.
• Proficient in managing multiple projects, budgets, and matrix interactions (internal / external consistent with each research project).Ability to strategically prioritize, deliver on time while embracing cultural diversity in complex environments.

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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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