Medical Director, Clinical Development, Hepatology
Core
Lead clinical development activities for liver disease assets, planning registrational studies and ensuring regulatory compliance.
Role type
Senior Medical Director, Clinical Development
Builds
Clinical development plans, study protocols, regulatory submissions, and integrated evidence strategies for hepatology assets.
Domain
Pharmaceuticals / Hepatology
Required skills
Medical degree, Internal Medicine or Primary Care board qualification, clinical residency completion, pharmaceutical industry clinical drug development experience, in-stream medical oversight experience, knowledge of ICH guidelines and FDA requirements, clinical research methodology, biostatistical principles
Preferred skills
Hepatology specialty training, MASH or ALD drug development experience, clinical research experience in hepatology, site-facing interactions with medical affairs or patient advocacy, team leadership, regulator and payor engagement, genetic data integration, statistical and data visualization methods
Technologies
digital tools, technology
Responsibilities
Contribute to indication planning and develop Target Product Profiles and clinical development plans; oversee R&D evidence generation and patient safety; design and execute clinical development plans across advanced stages; lead regulatory interactions and submissions; provide medical monitoring and oversight of study participants; act as clinical lead on Study Leadership Teams; evaluate business development activities and due diligence; stay abreast of therapeutic area advancements.
Seniority
Senior, hands-on IC