Senior Director Clinical Operations-CNS
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.
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