Executive Medical Director, Hepatology

Role Summary

Executive Medical Director, Hepatology, to lead an expanding hepatology program and drive late-stage asset development while exploring lifecycle opportunities to maximize therapeutic and commercial impact. Reports to the VP Clinical Development, CRH, GI & Renal in the RIIRU Advanced Pipeline Unit (APU). On-site presence is required at one of GSK’s US or UK sites (Cambridge, MA; Upper Providence, PA; Stevenage; London).

Responsibilities

• Strategic Leadership: Provide medical and scientific leadership for a hepatology asset, driving strategy to achieve clinical, regulatory, and commercial milestones while ensuring alignment with GSK’s strategic priorities.
• Late-Stage Drug Development: Oversee the design, initiation, execution, and closure of late-stage clinical trials, including Phase 3 studies, ensuring delivery of high-quality data to support regulatory approval and commercialization.
• Global Regulatory Interactions: Lead critical regulatory activities, including dossier submissions, preparation for meetings with health authorities (e.g., FDA, EMA, PMDA), and responses to regulatory queries.
• Life-Cycle Management: Identify, develop, and execute strategies to expand the asset beyond its primary indication, exploring significant life-cycle opportunities to maximize its therapeutic and commercial potential.
• Cross-Functional Collaboration: Leverage significant experience working across a complex cross-functional matrix to partner with clinical, translational, commercial, regulatory, and scientific teams.
• Innovation and Competitive Intelligence: Monitor emerging trends, competitor activities, and advancements in hepatology and related fields to identify opportunities for differentiation and strategic growth.
• Team Leadership: Lead and mentor a high-performing team, fostering professional development, providing clear direction, and ensuring alignment with GSK’s values and objectives.
• External Representation: Act as a key representative of RIIRU in hepatology, engaging with external stakeholders, scientific forums, and professional organizations to advance the company’s visibility and influence in this therapeutic area.

Qualifications

• Required: Medical degree and clinical medical specialty training board qualification/registration.
• Required: Experience in the global pharmaceutical/biotechnology industry in the field of hepatology.
• Required: Experience in clinical research and drug development, with a focus on hepatology.
• Required: Line-management experience overseeing medical directors and/or clinical scientists as well as leading matrix teams within a clinical development setting.
• Required: Experience in late-stage hepatology drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure.
• Preferred: Medical degree and clinical medical specialty training board qualification/registration in Gastroenterology or Hepatology.
• Preferred: Demonstrated success in life-cycle management, including identifying opportunities for indication expansion and strategic development beyond primary indications.
• Preferred: Experience with regulatory interactions, including submissions, strategy meetings, and negotiations with health authorities.
• Preferred: Understanding of the clinical and scientific landscape in hepatology, experience in advancing innovative therapies.
• Preferred: Experience in translational medicine and biomarker development.

Additional Requirements

• On-site presence required (minimum two days per week) at one of GSK’s US or UK sites (Cambridge, MA; Upper Providence, PA; Stevenage; London).