Role Summary
The Senior Medical Director leads designated aspects of Medical Affairs strategic planning and implementation for the Global Medical Leader (GML), collaborating with peers and other functions within the medical affairs team. The role mirrors parts of the GML scope and is accountable to the GML. Location: Baar Onyx, UK – London; USA – Pennsylvania – Upper Providence.
Responsibilities
- Gathers medical insights from Franchise LOCs and external stakeholders (HCPs, patients, payors, regulators) to shape the integrated evidence strategy and global medical affairs plans.
- Leads medical lead research activities including GSK-sponsored studies, Investigator-initiated and supportive collaborative studies, as well as expanded Access Programs.
- Leads Advisory Board design and discussions ensuring compliance with SE governance and documentation requirements.
- Leads Symposia and other Educational Activities design and discussion ensuring compliance with SE governance and documentation requirements.
- Leads and provides inputs to the design and delivery of phase IIIb/IV studies and EAPs, including post-approval commitments, coordinating with relevant R&D technical experts e.g., Global Health Organization and Epidemiology.
- Works closely with data generation leads, clinical development leads, clinical operations to operationalize the GMA funded studies.
- Insights & Listening Strategy: Lead the insights and listening priorities, translating stakeholder feedback into actionable impact across medical strategy and evidence generation.
- Congress & External Expert Engagement: Serve as the Congress and EE engagement lead, managing scientific presence, symposia, and interactions at major hematology and oncology conferences.
- Advisory Boards & Steering Committees: Organize and lead advisory boards for MF, VEXAS, and MDS, and chair the KEE steering committees, ensuring expert input informs clinical and medical plans.
- Global Medical Network (GMN) Leadership: Act as the GMN lead, facilitating cross-functional collaboration and knowledge sharing across global and local medical teams.
- Scientific Content Governance: Serve as scientific reviewer and approver for materials in the Content Lab, ensuring compliance, accuracy, and strategic alignment.
- Plays an integral role in the development and approval of brand strategy, and promotional campaigns and materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc).
- Supports the GML in communicating effectively the clinical and market access data for their asset to the Franchise LOCs; ensures a robust understanding of risk: benefit.
- Enhances local tactical plans and shares best practices to support Launch Excellence.
- Supports the GML in providing medical governance oversight for the asset, including management of product-related issues with potential impact on patient safety, and medical budget management.
- Responsible for leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s).
- Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
Qualifications
- Required: Medical Doctor, PharmD or PhD
- Required: Over 5 years experience in the haematology therapeutic area
- Required: Broad drug development experience with robust knowledge of GCP regulatory/market access and reimbursement requirements in EU and other markets
- Required: Ability to develop, design and implement expanded access program studies
- Required: Experience in Global Medical Affairs and life cycle management, including launch & reimbursement requirements in US/EU/UK markets
- Required: Experience working in an incountry role aswell as a global role
- Preferred: Robust understanding of promotional codes/regulations; previous involvement in review and approval processes
- Preferred: Highly developed leadership, networking, communication, intercultural communication skills and influencing skills to work effectively in a complex matrix and global environment
- Preferred: Demonstrated ability to build strong internal and external networks
- Preferred: Ability to work across time zones and to travel
- Preferred: Experience in operationalising clinical studies
- Preferred: Disease and therapeutic area knowledge of Myelofibrosis/MPNs and or Myelodysplastic Syndromes
Education
- Medical Doctor, PharmD or PhD (educational requirement)
Skills
- Strategic medical affairs planning
- Evidence generation and integrated evidence planning
- Scientific engagement with HCPs, patients, payors and regulators
- Cross-functional leadership in a global matrix
- Regulatory and market access knowledge
- Advisory boards and congress management
Additional Requirements
- Travel and ability to work across time zones as required