Director, Clinical Operations

Overview

In this role you will lead Neurocrine’s Clinical Operations for all study phases, ensuring regulatory compliance and on-time delivery of programs. You will oversee CROs, vendors, and cross-functional partners to meet budgets and timelines, while developing the careers of the clinical operations team. You will shape clinical strategies and drive process improvements to achieve program objectives. This is a hands-on leadership role in a fast-paced environment that values strategic thinking and accountability.

Responsibilities

• Design and implement clinical strategies using internal and external resources
• Provide leadership to the Clinical Operations study team
• Lead tactical execution of the clinical development process (all phases) for selected programs
• Ensure compliance with FDA regulations, EU directives, ICH guidelines and SOPs
• Manage overall clinical program budgets and individual study budgets
• Develop and maintain clinical trial timelines to achieve corporate goals
• Create metrics to benchmark performance and drive continuous improvement
• Identify and implement process improvements within the clinical organization
• Manage relationships with CROs and other clinical contract service providers
• Interface with Medical Directors to provide operational input to protocols and development plans
• Recruit, train, and develop direct reports within clinical operations
• Manage operational activities of clinical programs with corporate partners
• Perform additional tasks as assigned

Key requirements

• BS/BA in scientific or related field with 12+ years in clinical research in pharma/biotech or CRO
• or Master/MBA with 10+ years of relevant experience
• Extensive knowledge of clinical drug development, ICH, GCPs, FDA regulations and EU directive
• Experience directing global studies, especially in endocrine indications or rare diseases
• Strong leadership and ability to motivate and manage personnel
• Strategic vendor management skills, especially CROs
• Internal thought leader with broad function and scientific/business expertise
• Ability to operate independently in a multi-level matrix environment
• Excellent organizational, interpersonal, and negotiating skills

• leadership
• collaboration
• negotiation
• clinical drug development
• ICH, GCPs, FDA regulations, EU directive
• vendor management (CROs)

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