Assoc Clinical Development Director
Core
Lead scientific planning, execution, and reporting for late-stage inflammatory bowel disease (IBD) clinical studies, specifically supporting the emvistegrast program.
Role type
Associate Director, Clinical Development (Clinical Research)
Builds
Clinical trial protocols, data analysis plans, regulatory documents, and study results for Gilead's inflammation portfolio.
Domain
Biopharma / Immunology / Inflammation
Required skills
Clinical trial design, protocol preparation, data analysis, regulatory document preparation, Good Clinical Practice (GCP) adherence, scientific presentation
Preferred skills
Immunology/inflammation therapeutic area experience, FDA/EMA regulations knowledge, ICH guidelines familiarity, global travel
Technologies
None explicitly listed
Responsibilities
Develop study concept sheets and protocols; participate in protocol review discussions; prepare study manuals and investigator meeting notebooks; contribute to CRF and data management manual design; address scientific questions from investigators; prepare data listings and manuscripts; assist in regulatory document preparation; coordinate teams; provide clinical monitoring.
Seniority
Senior, hands-on IC
