Executive Medical Director, Hepatology

Role Summary

Executive Medical Director for Hepatology overseeing an expanding hepatology program, directing late-stage development and life-cycle management to maximize therapeutic and commercial impact.

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 strategic priorities.
• Late-Stage Drug Development: Oversee design, initiation, execution, and closure of late-stage clinical trials, including Phase 3 studies, to deliver high-quality data for regulatory approval and commercialization.
• Global Regulatory Interactions: Lead regulatory activities, including dossier submissions and meetings with health authorities, and responses to regulatory queries.
• Life-Cycle Management: Identify and execute strategies to expand the asset beyond its primary indication to maximize therapeutic and commercial potential.
• Cross-Functional Collaboration: Partner with clinical, translational, commercial, regulatory, and scientific teams in a complex matrix.
• Innovation and Competitive Intelligence: Monitor trends and competitor activities to identify differentiation and growth opportunities in hepatology.
• Team Leadership: Lead and mentor a high-performing team, ensuring professional development and alignment with values and objectives.
• External Representation: Represent RIIRU in hepatology, engaging with external stakeholders, forums, and professional organizations to advance visibility and influence.

Qualifications

• Medical degree and clinical specialty training board qualification/registration.
• Experience in global pharmaceutical/biotechnology industry in hepatology.
• Experience in clinical research and drug development with a hepatology focus.
• 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 board qualification/registration in Gastroenterology or Hepatology.
• Success in life-cycle management, including opportunities for indication expansion beyond primary indications.
• Experience with regulatory interactions, including submissions and strategy meetings with health authorities.
• Understanding of the hepatology landscape and experience advancing innovative therapies.
• Experience in translational medicine and biomarker development.

Education

• Medical degree; clinical specialty training.