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Job description
About The Role
Responsible for developing strategic plans, objectives, and overall management for the Clinical Operations team executing Neurocrine’s clinical studies (all phases). Ensure clinical study activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and adherence to corporate/departmental Standard Operating Procedures. Oversee CROs, external vendors, and internal stakeholders to ensure studies meet timelines, budgets, and resources. Manage career development for multiple direct reports.
Your Contributions
Design and implement clinical strategies using internal and external resources
Provide leadership to the Clinical Operations study team
Lead tactical implementation and execution of the clinical development process (all phases) for selected programs
Ensure activities comply with FDA/EU/ICH and corporate/departmental SOPs
Establish and manage clinical program and individual study budgets
Develop and maintain clinical trial timelines to achieve corporate goals
Create and benchmark critical metrics; drive process improvements
Manage CRO/vendor relationships and act as point of contact with external bodies
Coordinate with Regulatory, QA, and other functions; support cross-functional meetings and documentation
Provide operational input to clinical protocols, development plans, and clinical study reports
Recruit, train, and manage direct reports
Manage operational activities with corporate partners
Requirements
BS/BA in scientific/related field + 12+ years clinical research experience (pharma/biotech or CRO) including ICH/GCP/FDA/EU; prior global study leadership (endocrine and/or rare diseases) OR
Master’s/MBA + 10+ years similar experience OR extensive managerial experience
Detailed knowledge of clinical drug development (ICH/GCP/FDA/EU)
Ability to manage/mentor/train, influence, and motivate
Expertise directing global studies (endocrine and/or rare diseases)
Strategic vendor management (CROs)
Strong leadership, organizational, negotiation/influencing skills, and ability to work in a matrix environment
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.