Associate Director Clinical Operations
Job Description
🔍 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 that’s 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.
- Bachelor’s 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.