Associate Director, Clinical Development
Core
Lead scientific planning, execution, and reporting for late-stage inflammatory bowel disease (IBD) clinical trials, including protocol development and regulatory support.
Role type
Senior IC clinical development scientist (IBD)
Builds
Clinical study protocols, data analysis plans, and regulatory documents for Gilead's development compounds in inflammation.
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, drug development phase knowledge, FDA/EMA/ICH guidelines familiarity, global travel
Technologies
None stated
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 and provide direction; provide clinical monitoring for studies.
Seniority
Senior, hands-on IC