Medical Director, Clinical Development, Hepatology

About the role

Initially based at the Stevenage site (temporary), with a planned relocation to Cambridge, UK by early 2029. GSK aims to positively impact the health of 2.5 billion people by the end of the decade through discovering and delivering vaccines and medicines. The role sits within the Respiratory, Immunology and Inflammation Research Unit (RIIRU), formed in 2024 to identify and advance novel molecular targets with genetic associations to disease. Working model: hybrid – on‑site at least two days per week, remote work available other days. Position summary: A Medical Director, Clinical Development, Hepatology is sought to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on liver diseases. You will work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies, reporting to the Clinical Development Lead.

Responsibilities

• Contribute to project team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to support vital deliverables including the Target Product Profile (TPP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning.
• Provide effective support to the development and execution of the IES, including oversight of R&D evidence generation activities to ensure patient safety and study delivery.
• Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input (patients, evidence generation, regulators, payors, pharmacovigilance, etc.).
• Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols, amendments, investigator brochures, clinical study reports, etc.
• Input to, and may lead, regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
• Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician. If physician, accountability for Medical Govern