Clinical Development Director - Hepatology

Role Summary

The Clinical Development Director - Hepatology provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the RIIRU. The role involves planning, executing, and delivering hepatology translational and clinical development strategies and studies, particularly for steatotic liver disease, and developing clinical development plans up to proof of mechanism/proof of concept.

Responsibilities

• Support alignment of translational and clinical plans and study designs with project strategies; develop sections of core regulatory documents.
• Generate data and evidence to determine efficacy, safety, and differentiation of medicines, delivering value to patients quickly.
• Define and deliver clinical pillars of the translational table; deliver study timelines and endpoints including pharmacology, mechanism and clinical efficacy endpoints; establish Go/No Go criteria for the CDP.
• Maintain relationships with program counterparts across Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs, and Statistics.
• Contribute to implementation and embedding of strategic and organizational initiatives in Clinical Development.
• Provide oversight of R&D evidence generation activities to ensure patient safety and study delivery.
• Contribute to indication planning and integrate input from multiple disciplines to deliver key artifacts such as Medicine Profile, Target Validation, Translational Plans, and Candidate Selection.
• Design clinical development plans and study protocols across all phases; develop clinical study documents (protocols, amendments, brochures, reports).
• Provide input to regulatory interactions and documents, including briefing documents and responses for assigned studies.
• Provide medical monitoring and oversight of participant safety; accountable for Medical Governance where applicable.
• Lead the Clinical Management Team on an EPU program; act as Clinical Lead at study level; interface with RIIRU/GSK review boards and protocol review boards.
• Evaluate business development opportunities from a clinical perspective.
• Stay informed on hepatology research advancements, trial methodologies, regulatory space; identify opportunities with high patient impact.
• Integrate inputs from scientific, clinical, commercial, and regulatory areas into Medicine Profile components; contribute to solving development plan challenges.
• Influence across project, departmental, and cross-departmental levels as appropriate.

Qualifications

• PhD or PharmD (or equivalent) with 1–3 years postgraduate experience; minimum of 3 years in clinical research and development.
• Knowledge and experience in translational studies and preclinical biology; hepatology research priorities and treatment guidelines.
• Experience with global regulatory agencies and global hepatology clinical trials; knowledge of GCP and ethical guidelines.

Preferred Qualifications

• Medical Degree (MD/DO) preferred.
• Board certification/eligibility in hepatology; internal medicine background also suitable.

Skills

• Clinical development strategy and program design
• Cross-functional collaboration and stakeholder management
• Regulatory and medical governance knowledge
• Strategic thinking and problem solving in translational medicine

Education

• PhD or PharmD or medical degree (preferred)