Director, Clinical Operations

Job Description

Director, Clinical Operations | Neurocrine Biosciences

The Tone:
This is a full-time leadership role at Neurocrine Biosciences. The company focuses on discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. This position is critical for developing strategic plans and managing the Clinical Operations team, ensuring that clinical studies are executed in compliance with regulations and achieve corporate goals.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: Not specified

• Team: Provides leadership to the Clinical Operations study team (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees), and manages multiple direct reports.
• Mission: Owns the strategic planning, execution, and overall management of Neurocrine’s clinical studies across all phases, ensuring compliance, budget adherence, and timely achievement of program objectives.

What You’ll Actually Do
• Design and implement clinical strategies, providing leadership for the Clinical Operations study team and leading the tactical execution of clinical development processes across all phases.
• Establish and manage overall clinical program and individual study budgets, developing and maintaining timelines to achieve corporate goals.
• Ensure clinical study activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and corporate/departmental Standard Operating Procedures.
• Manage relationships and expectations with CROs, external vendors, and internal stakeholders to ensure studies are conducted according to timelines, budgets, and resources.
• Recruit, train, and manage the career development of multiple direct reports within the clinical operations group.

The Must-Haves
• Background: BS/BA degree in a scientific or related field. This role requires extensive experience with traditional progression in clinical research within the pharmaceutical/biotech industry or CRO, culminating in a Director-level position.
• Experience: 12+ years of clinical research experience with a BS/BA, or 10+ years with a Master’s degree in a scientific or related field or an MBA. Includes extensive previous managerial experience and expertise directing global studies, particularly in endocrine-related indications and/or rare diseases.
• Skills: Detailed working knowledge of clinical drug development processes including ICH, GCPs, FDA regulations, and EU directives. Strategic vendor management skills, particularly with CROs. Ability to effectively manage, mentor, and train personnel, alongside strong organizational, interpersonal, and leadership capabilities.