Clinical Development Medical Director- Hepatology

Role Summary

Clinical Development Medical Director - Hepatology acts as a translational leader within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). Provides medical and scientific expertise to pre-clinical, clinical and translational studies, leading programs or project teams to concept, design, plan and execute projects including first-time-in-human trials, experimental medicine studies and translational data generation. Works cross-functionally to develop and execute clinical development plans up to proof of mechanism/concept, with a focus on steatotic liver disease (including MASH and ALD) and chronic Hepatitis B.

Responsibilities

• Drive development of clinical plans and study designs aligned with translational plans and project strategies; develop sections of core regulatory documents.
• Generate data and evidence to determine potential efficacy, safety profile, product differentiation, and route to value for patients in the shortest timeframe.
• Deliver clinical development timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints; establish Go/No Go criteria for the CDP.
• Maintain relationships with program counterparts in Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
• Contribute to the implementation and embedding of strategic and organizational clinical development initiatives.
• Design clinical development plans and study protocols across all development phases, reflecting stakeholder input (patients, regulators, payors, pharmacovigilance).
• Develop clinical study protocols, amendments, investigator brochures and clinical study reports.
• Contribute to indication planning, incorporating input from scientific, clinical, regulatory, regulatory, stats and other disciplines to deliver key artifacts.
• Provide oversight of R&D evidence generation activities to ensure patient safety and study delivery; input to regulatory interactions and documents.
• Provide medical monitoring and safety oversight during studies in collaboration with Pharmacovigilance; maintain governance of scientific integrity and participant safety.
• Lead end-to-end clinical development strategy for an EPU program; serve as clinical lead at study level and interface with internal governance boards.
• Collaborate with cross-functional teams to ensure cohesive translational and clinical development plans; evaluate business development opportunities.
• Stay current on hepatology research, trial methodologies, regulatory space and competitive landscape; identify transformational opportunities benefiting patients.
• Influence across projects and departments to contribute to clinical components of Medicine Profiles and overall development plans.

Qualifications

• Required: Medical Degree; completion of clinical residency and specialty training, ideally with hepatology experience; experience in preclinical or clinical R&D; experience with translational studies and human translational data; robust knowledge of hepatology research priorities and regulatory/guidance frameworks (GCP, ethics).
• Preferred: PhD or higher research degree; board certified/eligible in gastroenterology with hepatology focus; experience with global regulatory agencies and global hepatology clinical trials.

Skills

• Clinical leadership and program management; ability to lead cross-functional teams and represent clinical perspectives to internal and external stakeholders.
• Strategic thinking with ability to translate scientific insights into development plans; strong collaboration and communication skills.
• Medical monitoring and pharmacovigilance oversight; ability to manage risk and ensure patient safety in trials.
• Regulatory writing and briefing/document preparation; aptitude for navigating complex regulatory interactions.
• Adaptability in a matrix organization and ability to influence without direct authority.

Education

• Medical degree required; completion of residency and specialty training, ideally including hepatology.
• Additional advanced degree or fellowship in hepatology or related translational/biomedical field preferred.