Meet Life Sciences
Associate Director Clinical Operations (San Jose)
Meet Life Sciences, San Jose, California, United States, 95199
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. 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.
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. 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.