Senior Director Clinical Operations-CNS

EPM Scientific; San Francisco (CA); Hybride; USD 150 000 - 200 000; Plein temps

Résumé du poste

A leading biotechnology company is seeking a Senior Director of Clinical Operations in the San Francisco Bay Area. The individual will oversee strategic planning and execution of CNS-focused clinical programs, ensuring compliance with global regulatory standards. The ideal candidate has over 15 years of clinical operations experience and a strong leadership background in the CNS therapeutic area. This is a full-time, hybrid role offering competitive compensation.

Qualifications

• 15+ years of clinical operations experience in biotech/pharma.
• 10+ years in leadership roles within the CNS therapeutic area.
• Proven track record managing global Phase I-III trials.

Responsabilités

• Lead strategic planning for CNS clinical programs.
• Develop operational strategies, timelines, and budgets.
• Ensure compliance with ICH/GCP guidelines and regulatory requirements.

Connaissances

Leadership

Clinical Operations Management

Vendor Management

Regulatory Compliance

Problem-Solving

Formation

Bachelor's degree in Life Sciences or related field

Description du poste

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