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Associate Director Clinical Operations (Fremont)
Meet Life SciencesFremont, CA, US7 days ago
Job type
- Part-time
Job description8+ 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. Bachelors 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.
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 :
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Associate Director Clinical • Fremont, CA, US
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