Global Medical Affairs Lead
Site Name: USA - Maryland - Rockville Posted Date: Jul 22 2021 Job Purpose Provide global medical affairs leadership ensuring consolidated, strategic medical input into R&D and commercialisation strategies for Shingrix. 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. Key Responsibilities Provides global medical affairs leadership for an assigned assets 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. Accountable for GMATs and 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 LCM plans. 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 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 SMM and MM Required qualifications and previous experience: Required: Physician (MD or equivalent) At least 10 years industry and/or clinical experience in the relevant field, acquired through global/regional/Local Medical Affairs or relevant non-Medical Affairs functional areas: e.g. regulatory affairs, clinical, epidemiology, market access, discovery etc. 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. Must demonstrate disease area expertise and appropriate medical and/or clinical experience. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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