Director, Clinical Development (MD)
Core
Lead clinical trial programs for Inflammation/Fibrosis diseases (PBC, MASH), acting as Physician Responsible for assigned projects.
Role type
Senior IC clinical development physician (MD)
Builds
Late-stage therapeutic products for global registration
Domain
Biopharma, Hepatology/Gastroenterology, Inflammation/Fibrosis
Required skills
Clinical trial program leadership, study protocol design, regulatory documentation, medical monitoring, data synthesis, cross-functional team management, scientific presentation
Preferred skills
Board certification in hepatology/gastroenterology, experience in biopharma industry, familiarity with medical monitoring and drug safety surveillance
Technologies
None stated
Responsibilities
Lead development of Target Product Profile and Clinical Development Plan; provide scientific/clinical guidance to cross-functional teams; lead clinical trial protocol design and study reports; perform ongoing medical monitoring including eligibility and toxicity assessment; manage preparation of regulatory documents and investigator brochures; coordinate data collection and analysis; present scientific information at conferences.
Seniority
Senior, hands-on IC
