Executive Director, Clinical Operations
confidentialMillbrae (CA)
Executive Director, Clinical Operations
Posted today
confidentialMillbrae (CA)
SENIORITY
Manager
About the role
Executive Director, Clinical Operations
About the Company:
Innovative biotechnology (BioTech) company specializing in IBD & immune-mediated disease products IndustryBiotechnologyTypePublic Company Founded2023Employees51-200
About the Role:
The Company is seeking an Executive Director of Clinical Operations to provide strategic leadership and hands-on oversight of global clinical trials. The role leads operational planning and trial execution from feasibility and start-up through enrollment, database lock, and closeout, ensuring delivery against timelines, budgets, quality standards, and regulatory requirements. Responsibilities include overseeing CROs, vendors, sites, budgets, enrollment strategies, risk mitigation, and inspection readiness. The Executive Director will collaborate across clinical and other functions, report study progress and key risks to senior leadership, and mentor Clinical Operations staff. Candidates must have a bachelor's degree in a scientific, healthcare, or related discipline and at least 10 years of global clinical research experience in the pharmaceutical or biotechnology industry; an advanced degree is preferred. Required qualifications include a record of overseeing clinical trials across the full study lifecycle, managing CROs and vendors, and strong financial, operational, and risk-management skills. Thorough knowledge of Good Clinical Practice and applicable clinical trial regulations is essential, along with experience supporting audits and inspections. Late-stage dermatology trial experience is strongly preferred, as are contributions to protocols, standard operating procedures, clinical study reports, or regulatory submissions. Hiring Manager TitleChief Executive Officer (CEO) Functions Operations
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