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Job description
Senior Director, Clinical Operations - CNS
Location: San Francisco Bay Area (Hybrid)
About the Role
We are seeking an experienced Senior Director of Clinical Operations to lead the strategic planning and execution of our CNS-focused clinical programs. This individual will play a critical role in ensuring the successful delivery of early and late-phase clinical trials, working cross-functionally to drive operational excellence and compliance with global regulatory standards.
Key Responsibilities
Provide strategic leadership and oversight for all CNS clinical programs from start-up through close-out.
Develop and implement operational strategies, timelines, and budgets to ensure on-time, on-budget delivery of clinical trials.
Oversee vendor and CRO selection, contracting, and performance management.
Lead the development and review of key clinical documents (protocols, ICFs, study manuals, investigator brochures, CSRs).
Ensure compliance with ICH/GCP guidelines, SOPs, and regulatory requirements.
Collaborate closely with Clinical Development, Regulatory, Data Management, and Pharmacovigilance teams.
Manage and mentor a high-performing Clinical Operations team.
Provide regular updates to executive leadership on program status, risks, and mitigation strategies.
Qualifications
Bachelor's degree in Life Sciences or related field (advanced degree preferred).
15+ years of clinical operations experience in biotech/pharma, with 10+ years in leadership roles .
Proven track record in CNS therapeutic area (neurology, psychiatry, neurodegenerative disorders).
Strong experience managing global Phase I-III trials.
Expertise in vendor/CRO oversight and budget management.
In-depth knowledge of GCP/ICH guidelines and regulatory requirements.
Exceptional leadership, communication, and problem-solving skills.
Employment type
Full-time
Job function
Science and Product Management
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.