Job Details

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:

• 8+ years of clinical operations experience in biotech, pharma, or CRO settings.
• Experience leading studies in various therapeutic areas, specifically non-oncology focused.
• Candidate with strong leadership acumen.
• Strong working knowledge of GCP, ICH, and FDA regulations.
• Bachelor's degree in a scientific discipline (Advanced degree preferred).
• Proven ability to lead cross-functional teams, multitask, and drive clinical timelines forward.
• A self-starter who communicates clearly, collaborates well, and excels in fast-paced environments.