Associate Director, Clinical Scientist
Core
Lead clinical science activities for assigned studies in gastrointestinal drug development, coordinating protocol development, data review, and regulatory interactions.
Role type
Senior IC clinical research scientist (clinical development)
Builds
Clinical study protocols, reports, and regulatory submissions for GI therapeutics
Domain
Pharmaceutical / Gastrointestinal clinical trials
Required skills
Clinical trial design and conduct, protocol development, data review and interpretation, regulatory affairs collaboration, cross-functional leadership, GCP compliance
Preferred skills
Rare disease experience, advanced degree (PhD, MD, PharmD), external vendor management
Technologies
Clinical trial management systems, statistical software
Responsibilities
Lead study-level clinical science coordination, author study protocols and amendments, review emerging study data and resolve deviations, partner with biostatistics and regulatory teams, represent the function on study management teams, provide clinical input to regulatory documents and health authority interactions
Seniority
Senior, hands-on IC