Associate Director Clinical Operations

Title : Associate Director, Clinical Operations

Hybrid Role : 3x / week in South San Francisco, CA

Our start-up biotech client is hiring a new Associate Director, Clinical Operations to lead a high-profile Phase 2 study expanding globally.

Key Responsibilities :

• Lead oversight of CROs, labs, and vendor partners to ensure delivery on timelines and budget.
• Drive the creation and execution of study documents including protocols, ICFs, CRFs, and operational plans.
• Manage IRB / regulatory submissions and support study start-up activities including site selection, initiation, and investigator meetings.
• Oversee Trial Master File (TMF) setup and maintenance.
• Coordinate investigational product supply and clinical sample logistics across sites and labs.
• Monitor study performance metrics, review clinical data, and proactively identify risks or deviations.
• Report regularly to senior leadership with trial updates and mitigation plans.

Qualifications :