Overview
Executive Medical Director to lead an expanding Hepatology program at GSK, advancing an asset through late-stage development and exploring lifecycle opportunities to maximize therapeutic and commercial impact. This position reports to the VP Clinical Development, CRH, GI & Renal in the RIIRU Advanced Pipeline Unit (APU).
Site Note: On-site presence required (minimum two days a week) in one of GSK’s US (PA or MA) or UK (London or Stevenage) sites.
About RIIRU: The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with human genetic associations to disease. The remit is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. External and internal partnerships support this goal.
Responsible for: Strategic leadership, late-stage development, global regulatory interactions, lifecycle management, cross-functional collaboration, external representation, and team leadership within a hepatology portfolio.
Why this matters: This role focuses on driving clinical, regulatory, and commercial milestones and aligning with GSK’s strategic priorities in hepatology.
Important: This opportunity requires on-site presence as noted above.
Key Responsibilities
* Strategic Leadership: Provide medical and scientific leadership for a hepatology asset, directing strategy to achieve clinical, regulatory, and commercial milestones while aligning with GSK’s priorities.
* Late-Stage Drug Development: Design, initiate, execute, and close late-stage trials (Phase 3), delivering high-quality data to support regulatory approval and commercialization.
* Global Regulatory Interactions: Lead dossier submissions, prepare for health authority meetings (FDA, EMA, PMDA), and address regulatory queries.
* Life-Cycle Management: Identify and execute strategies to expand the asset beyond its primary indication with significant lifecycle opportunities.
* Cross-Functional Collaboration: Partner across clinical, translational, regulatory, commercial, and scientific teams within a complex matrix.
* Innovation and Competitive Intelligence: Monitor hepatology trends and competitors to identify differentiation opportunities and strategic growth.
* Team Leadership: Lead and mentor a high-performing team, fostering development and alignment with GSK values.
* External Representation: Represent GSK/RIIRU externally with stakeholders, forums, and professional organizations to raise visibility in hepatology.
Basic Qualifications
* Medical degree and clinical specialty training board qualification/registration.
* Experience in the global pharmaceutical/biotechnology industry in hepatology.
* Experience in clinical research and drug development focusing on hepatology.
* Line-management experience overseeing medical directors and/or clinical scientists and leading matrix teams.
* Experience in late-stage hepatology drug development, including Phase 2 and Phase 3 design, initiation, execution, and closure.
Preferred Qualifications
* Medical degree and clinical specialty training in Gastroenterology or Hepatology.
* Success in lifecycle management, including indication expansion and strategic development beyond primary indications.
* Experience with regulatory interactions, submissions, strategy meetings, and negotiations with health authorities.
* Understanding of the hepatology clinical/scientific landscape and advancing innovative therapies.
* Experience in translational medicine and biomarker development.
GSK is an Equal Opportunity Employer. This role may require compliance with US CMS/Open Payments reporting requirements where applicable. For accommodations, contact the GSK Service Centre.
Legal/Operational: GSK does not accept referrals from employment agencies without prior authorization. See corporate policies for details.
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