EPM Scientific
Senior Director Clinical Operations-CNS
EPM Scientific, San Francisco, California, United States, 94199
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.
If the following job requirements and experience match your skills, please ensure you apply promptly. 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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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.
If the following job requirements and experience match your skills, please ensure you apply promptly. 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