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Senior Director Clinical Operations-CNS
Senior Director Clinical Operations-CNSEPM Scientific • San Francisco, CA, United States
Senior Director Clinical Operations-CNS

Senior Director Clinical Operations-CNS

EPM Scientific • San Francisco, CA, United States
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.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

    • #J-18808-Ljbffr

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