Director, Clinical Scientist
Advanced Clinical
- Philadelphia, PA
- Permanent
- Full-time
- Develops scientific understanding of assigned program and protocol requirements
- Supports protocol design and development strategy for clinical trials
- Manages protocol development process; including writing support, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document
- Contributes to the development of Informed Consent Forms (ICF); reviews/supports finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol
- Authors and reviews study materials for clinical trial utilization and health authority submissions
- Supports study start-up/conduct/close-out activities as applicable in collaboration with clinical operations and CRO
- Supports country/site selection activities and CRA training
- Liaises with site staff personnel, as necessary.
- Develops charter for study committee(s) (e.g., DMC, SRC) and plans meetings and presentation preparation
- Contributes to activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans
- Supports Medical Monitor in data review analysis and interpretation of patient and study level data
- Collaborates with translational medicine and bioanalytical team to analyze and assess biomarker data.
- Scientific author / contributor to internal and external communications, such as protocol training, posters, publications, and advisory board meeting presentations
- Maintains knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to help ensure best practices
- Collaborates with study team members (including Clinical Operations, Drug Safety, Regulatory Affairs, Precision Medicine, Project Management) to ensure that key milestones are met on time and with high quality