Director, Clinical Development
Core
Lead clinical development for Inflammation/Fibrosis programs, including primary biliary cholangitis (PBC), managing late-stage therapeutic registration and postmarketing requirements.
Role type
Director, Clinical Development
Builds
Late-stage therapeutic products for global registration
Domain
Biopharma, Inflammation/Fibrosis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial program leadership, study protocol design, regulatory documentation preparation, data analysis planning, cross-functional team management, medical monitoring, Target Product Profile development
Preferred skills
Biopharma industry experience, medical monitoring expertise, familiarity with addressing medical concerns
Technologies
None stated
Responsibilities
Lead multiple components of clinical trial programs; provide scientific and clinical guidance to cross-functional teams; coordinate data collection and assimilation for internal analysis; present scientific information at conferences; manage clinical development components in regulatory document preparation
Seniority
Director, strategic leadership & hands-on execution
