Associate Director Clinical Operations

New Yesterday

???? We're Hiring: Senior Clinical Trial Manager / Associate Director, Clinical Operations ???? San Francisco Bay Area Hybrid (3 days onsite) ???? Therapeutic Focus: Neurology and/or Immunology Experience Required We're supporting a rapidly growing biotech company in the Bay Area thats 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 . The ideal candidate brings a proactive mindset, deep clinical operations experience, and thrives in fast-moving, cross-functional environments. ???? 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. Strong working knowledge of GCP, ICH, and FDA regulations . Bachelors 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.
Location:
Santa Rosa, CA, United States
Job Type:
FullTime
Category:
Management Occupations