Provide global medical affairs leadership across a portfolio of pipeline assets in early stages of research and development (R&D) up to licensure, 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(s) 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
Required qualifications and previous experience:
- Provides global medical affairs leadership for an assigned portfolio of assets in early development, which may include viral, bacterial, or targeted immunotherapies assets providing strategic medical insights into R&D and commercialization strategies.
- Responsible for strategic alignment with clinical development, 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.
- In alignment with the Global Medical Portfolio Lead (GMPL) the GMAL will implement and lead the early GMAT and represent as appropriate the assigned assets at governance boards / meetings.
- Lead the 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 optimize 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.
- Drives delivery of designated above-country elements of the MAP ensuring compliance with GSK statutory governance and documentation requirements and provide the overall framework/guidance for evidence generation activities.
- Develop Areas of Interest (AOIs) to support a clear (Investigator Sponsored Study) ISS program.
- Reviews local GSK-sponsored and ISS proposals from Key LOCs to assess their scientific merit and strategic need, liaising with R&D technical experts.
- Oversees strategy for medical congresses and ensure scientific points are tied to TPP.
- 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.
- Providing medical governance oversight for the asset, including leading the management of product-related issues/ crises with potential impact on patient safety.
- Ensures that all communications (internal and external) are scientifically accurate, balanced, remain aligned with product strategy, and compliant to applicable laws and regulations.
- Effective management of medical budget (MAP and IEP) for assigned assets.
- Provides direction, support and guidance to Senior medical manager and medical managers.
- Physician, PharmD or PhD.
- Significant industry and/or clinical experience in the relevant field, acquired through global/regional/Local Medical Affairs
- Knowledge and understanding of the development process from asset inception, early 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 US 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.
Additional relevant job skills and abilities
- Must demonstrate disease area expertise and appropriate medical and/or clinical experience.
- Deep knowledge of healthcare environment.
- Strong analytical skills to be able to assess and interpret scientific data and ability to input into the design and implementation of Phase 2 & 3b /4 studies.
- Highly 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. Ability to be a GSK spokesperson with media.
- Proficient in managing multiple projects, budgets, and matrix interactions (internal / external consistent with each research project).
- Proven ability to strategically prioritize, deliver on time while embracing cultural diversity in complex environments.
- Track record of successful people management experience.
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