Clinical Development Medical Director – Hepatology

• Provide effective support and oversight of R&D evidence generation strategy, plan and activities to ensure patient safety and on-time, in-full study delivery.
• Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc.) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection.
• Design clinical development plans, study protocols and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance).
• Bring clinical expertise to 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.
• Accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
• Define and deliver the clinical pillars of the translational table.
• 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.
• Accountable for leading the Clinical Matrix Team (CMT) for a program.
• Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study.

• Medical Degree
• Completion of a formal postgraduate clinical training, clinical residency or specialty training in Internal Medicine, Pathology, etc.
• Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
• Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
• Ability to apply clinical judgement to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework
• Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
• Strong scientific communication skills, with the ability to translate clinical data into clear insights for internal and external audiences.

Demonstrates expertise in clinical trial conduct, medical monitoring, and safety review, while effectively leading cross-functional teams to ensure patient safety and timely study delivery. Proficient in designing clinical development plans and protocols, with strong knowledge of GCP, ICH guidelines, and regulatory frameworks.

• Medical Degree
• Clinical Trial Conduct
• Medical Monitoring
• GCP and ICH Guidelines
• Cross-Functional Team Leadership

• Clinical Development Processes
• Study Protocol Design
• Clinical Data Interpretation
• Pharmacovigilance
• Safety Review

• Scientific Communication
• Clinical Judgement
• Collaboration

• Postgraduate Clinical Training
• Clinical Residency

• Regulatory Frameworks
• Translational Plans
• Clinical Matrix Team
• Patient Safety
• Evidence Generation