Director, Clinical Operations

Job description

POSITION SUMMARY: This director level position oversees and is responsible for all aspects of clinical development, including clinical research, operations, safety, and portfolio planning. The Director oversees vendor relationships, site selection and management, and contract and budget negotiations. This position will serve as a member of the Clinical Therapeutics leadership team and will provide input in developing the department’s overall strategies, budgets and plans. DUTIES AND RESPONSIBILITIES: - Supervise and manage the internal clinical team - Participate in designing and writing clinical trial protocols - Manage clinical site selection, trial agreements, and budget negotiations - Selection and management of vendors required for the conduct of clinical trials (e.g., Clinical Research Organizations, central labs, central Institutional Review Boards, analytical labs, etc.) - Negotiate vendor contracts and budgets throughout the lifecycle of clinical trials - Conduct investigational product forecasting and management - Design, review and approve ancillary forms - Review and approve clinical study documents including SAP, EDC design, validation specs, edit specs, annotated CRFs...