Senior Director, Clinical Operations
City Therapeutics · Cambridge, Massachusetts, US
SUMMARY: City Therapeutics is seeking a seasoned, Sr. Director-level subject matter expert to drive the advancement of our clinical programs while upholding...
Job description
SUMMARY: City Therapeutics is seeking a seasoned, Sr. Director-level subject matter expert to drive the advancement of our clinical programs while upholding our core values and mission. Reporting to the Head of Clinical Operations, the Senior Director will play a pivotal role in the strategic planning, oversight, and execution of one or more clinical programs. Please note this is a full-time onsite opportunity Key Responsibilities: - Program Oversight: Clinical operations leadership across assigned programs, including trial management, site monitoring, vendor selection and oversight, TMF, data operations, timeline and budget adherence - Document Development: Collaborate with cross-functional teams to contribute to protocols, project plans, timelines, statistical analysis plans, and final study reports. - Compliance & Quality: Ensure adherence to SOPs and GCP/ICH guidelines; maintain inspection readiness throughout the trial lifecycle. - Risk Management: Proactively identify, resolve, and escalate issues that could impact timelines or budgets. - Country and Site Strategy: Identify, evaluate, and recruit clinical trial locations and sites globally. - Regulatory Support: Contribute to...