Director, Clinical Development
Core
Lead clinical development for Inflammation/Fibrosis indications (e.g., primary biliary cholangitis, liver disease) across Phase 2-4 trials.
Role type
Director, Clinical Development
Builds
Clinical Development Plans, Target Product Profiles, regulatory documents, and scientific publications for liver disease therapies.
Domain
Biopharma / Clinical Development / Liver Disease
Required skills
Clinical study design, protocol strategy, medical monitoring, regulatory document preparation, cross-functional leadership, data analysis planning, scientific communication
Preferred skills
Liver disease expertise, complex project management, matrix management, regulatory filing experience, conference abstract submission
Technologies
Clinical trial management systems, statistical software, regulatory databases
Responsibilities
Lead clinical study design and protocol preparation; oversee medical monitoring and data cleaning; contribute to clinical study reports and regulatory submissions; lead scientific communication of study results; provide clinical guidance to cross-functional teams; manage study start-up, maintenance, and close-out.
Seniority
Director, strategic leadership with hands-on oversight