Associate Director Clinical Operations

5 Days Old

Overview We\'re supporting a rapidly growing biotech company in the Bay Area that\u2019s advancing a high-impact pipeline in the neurology and immunology space. They are seeking a Senior Clinical Trial Manager or Associate Director to lead and execute pivotal clinical trials with excellence and efficiency. This is a full-time, hybrid role based in the San Francisco Bay Area , with a requirement to be onsite 3x per week . Therapeutic Focus: Neurology and/or Immunology Experience Required Base pay range: $170,000.00/yr - $190,000.00/yr 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. Strong working knowledge of GCP, ICH, and FDA regulations . Bachelor\u2019s degree in a scientific discipline (Advanced degree preferred). Therapeutic experience in neurology or immunology strongly preferred (especially in MS ). 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. Job details Seniority level: Mid-Senior level Employment type: Full-time Job function: Management, Project Management, and Science Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Staffing and Recruiting
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Location:
San Francisco, CA, United States
Job Type:
FullTime
Category:
Bio & Pharmacology & Health