Clinical Development Medical Director - Hepatology

Clinical Development Medical Director - Hepatology

GSK is seeking a Clinical Development Medical Director – Hepatology to act as a translational leader within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The role will provide medical and scientific expertise to pre‑clinical, clinical and translational studies, leading initiatives such as first‑time‑in‑human trials, experimental medicine studies and translational data generation. The focus is on steatotic liver disease (MASH, ALD) and chronic Hepatitis

B.

• Drive development of clinical plans and study designs, ensuring alignment with translational plans and project strategies; develop sections of core regulatory documents.
• Generate data and evidence required to determine target or medicines' potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
• Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP.
• Seek and maintain relationships with program counterparts across disciplines including Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.

• Design clinical development plans and study protocols across all phases of development, reflecting internal and external stakeholder input.
• Develop clinical study protocols, amendments, investigator brochures and clinical study reports.
• Contribute to the study team discussions on indication planning, incorporating input from across disciplines to contribute to vital deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection.
• Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
• Input to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses.
• Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study.
• Governance across the project to ensure scientific integrity and overall safety of the study subjects.

• Lead the end‑to‑end clinical development strategy for an EPU program, accountable for leading the Clinical Management Team (CMT).
• Collaborate with cross‑functional teams to ensure cohesive and comprehensive translational and clinical development plans.
• Serve as the primary clinical interface with the relevant internal RIIRU/GSK review board and Protocol Review Board.
• Conduct clinical evaluation of business development opportunities.
• Stay abreast of advancements in hepatology research and clinical trial methodologies.
• Identify and highlight transformational opportunities to deliver significant benefit to patients.
• Support integration of inputs from across disciplines to contribute to clinical components of the Medicine Profile.
• Demonstrate ability to influence others at project, departmental and inter‑departmental levels.

• Able to consistently inspire others by setting a positive example and creating an environment where team members feel valued.
• Demonstrated experience in managing conflicts effectively and negotiating mutually acceptable solutions.
• Consistently achieves desired outcomes through strong influencing skills and persuasive arguments.

• Demonstrated flexibility and adaptability in changing environments, analyzing incomplete information.
• Collaborate across the matrix, integrating cross‑functional knowledge into decision‑making processes.
• Embrace challenge as an opportunity for creativity and use new learning and digital tools.
• Proactively generate ideas for innovative improvement and promote an…