Global Medical Affairs Director, Rheumatoid Arthritis, Open to flexible working
Otilimab is a fully human monoclonal antibody that inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a protein that plays a central role in a broad range of immune-mediated diseases, including rheumatoid arthritis. GM-CSF acts on cells, including macrophages (an immune cell type that plays a key role in the inflammatory process), leading to inflammation, joint damage and pain. Otilimab neutralises the biological function of GM-CSF by blocking the interaction of GM-CSF with its cell surface receptor.
GSK is currently conducting a phase 3 development program studying otilimab in rheumatoid arthritis. We have an exciting opportunity to join the otilimab global medical affairs team as Global Medical Affairs Director.
Your role will be to:
- Contribute to the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/ indication(s) under the direction of the GMAL
- Work closely with Global Medical Affairs team to optimise development plans.
- Lead/contribute to designated elements of the above-country Medical Affairs Plan e.g. Advisory Boards; Symposia.
- Partner with commercial colleagues to develop brand campaigns and support launches.
- Develop and approve promotional, non-promotional and training materials.
- Deliver the evidence needs of that asset in partnership with Franchise/ R&D colleagues, including:
- Supporting the efficient working of the Integrated Evidence Team;
- Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need;
- Developing assigned Franchise study protocols.
- Drive excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
- Leads gathering medical insights from the Franchise LOCs and external stakeholders (HCP's, Patients, Payors and Regulators) to shape the integrated evidence strategy and plan.
- Leads aspects of Advisory Board design and discussion, ensuring compliance with SE governance and documentation requirements.
- Inputs to the design and delivery of phase 3b/ 4 studies, coordinating with relevant R&D technical experts e.g. Value Evidence & Outcomes and Epidemiology as required.
- Supports preparation of materials for the Portfolio Investment Board review/ Brand Planning processes.
- Develops and approves promotional campaigns and materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc).
- Develops and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DPP) is maintained in Datavision.
- Communicating the clinical and market access data to the Franchise LOCs, ensuring a robust understanding of risk: benefit of our medicines.
- Enhances local tactical plans and shares best practices to support Launch Excellence.
- Works with GMAL in providing medical governance oversight for the asset, including the management of product-related issues/ crisis.
- Medical Doctor or PharmD / PhD
- Industry experience within immunology medical affairs.
- Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements.
- Ability to develop, design and implement Phase 3b /4 studies.
- Significant experience in Medical Affairs and life cycle management, including understanding of launch support requirements.
- Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes.
- Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
- Demonstrated ability to build strong networks of external and internal experts
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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