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 levelEmployment type : Full-timeJob function : Management, Project Management, and ScienceIndustries : Pharmaceutical Manufacturing, Biotechnology Research, and Staffing and Recruiting#J-18808-Ljbffr