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 in steatotic liver disease (SLD). The position collaborates cross-functionally to develop and execute clinical development plans up to Proof of Mechanism/Proof of Concept studies.

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 a target or medicines’ potential efficacy, safety profile, differentiation, and route to value for patients.
• Define and deliver the clinical pillars of the translational table; deliver timelines and endpoints including pharmacology, mechanism, and clinical efficacy endpoints; enable Go/No Go decisions for the CDP.
• Maintain relationships with program counterparts in Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs, and Statistics.
• Contribute to implementation of strategic and organizational initiatives in Clinical Development.
• Provide effective support and oversight of R&D evidence generation activities to ensure patient safety and study delivery.
• Contribute to indication planning discussions and integrate inputs across disciplines to deliver key documents (early Medicine Profile, Target Validation, Translational Plans, Candidate Selection).
• Design clinical development plans and study protocols across all development phases; incorporate stakeholder input.
• Develop clinical study protocols, amendments, investigator brochures, and clinical study reports; contribute to regulatory documents.
• Provide medical monitoring and oversight of participant safety; ensure scientific integrity and overall safety of study subjects.
• Lead the clinical development strategy for an EPU program; act as Clinical Lead at study level; interface with internal review boards and external stakeholders.
• Evaluate business development opportunities from a clinical perspective.
• Stay informed on hepatology research, trial methodologies, and regulatory space to maintain competitive edge; identify transformational opportunities.

Qualifications

• PhD or PharmD (or equivalent) with 1–3 years postgrad experience; minimum of 3 years of experience in clinical research and development.
• Knowledge and experience in translational studies including human translational data and preclinical experiments in relevant models.
• Robust knowledge of hepatology research priorities, public health needs, competitor landscape, and treatment guidelines evolution.
• Experience with global regulatory agencies and management of global hepatology clinical trials.
• Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.

• Preferred: Medical Degree; Board certified/eligible in hepatology; general internal medicine experience for MDs or relevant disease area experience.

Skills

• Clinical leadership and cross-functional collaboration
• Strategic planning and translational/clinical development design
• Regulatory and pharmacovigilance awareness
• Medical governance and safety oversight
• Communication and influencing skills; stakeholder management
• Adaptability in complex, matrix environments

Education

• PhD or PharmD (or equivalent); advanced degree aligned with hepatology or clinical development is preferred.