Associate Director - Clinical Development (Hepatology)
Core
Senior medical professional leading scientific and medical expertise for early-to-late-phase hepatology clinical trials to inform asset and portfolio decisions.
Role type
Senior IC clinical development lead (hepatology)
Builds
Clinical trial protocols, safety oversight, and regulatory documents for hepatology assets
Domain
Biopharmaceuticals / Hepatology
Required skills
Medical degree (MD), hepatology clinical practice, clinical trial design, protocol development, medical monitoring, safety oversight, regulatory document authoring, data interpretation, cross-functional collaboration, mentorship
Preferred skills
Clinical development experience in pharma/biotech, global interventional trials, GCP/ICH guidelines knowledge
Technologies
Clinical Study Reports (CSRs), Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs)
Responsibilities
Lead protocol development and amendments; serve as study medical monitor for safety and data quality; author regulatory documents; analyze clinical data; collaborate with cross-functional teams; provide expert input to operational plans; mentor junior scientists
Seniority
Senior, hands-on IC with mentorship responsibilities