Director, Clinical Operations

Job Description

Director, Clinical Operations | Neurocrine Biosciences

The Tone:
This is a full-time leadership role at Neurocrine Biosciences, located in San Diego, CA. Neurocrine Biosciences is dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. This role is crucial for developing strategic plans, setting objectives, and providing overall management for the Clinical Operations team, ensuring that clinical studies across all phases are executed in compliance with regulations and effectively advance the company’s robust pipeline of medicines.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: In-person, San Diego, CA
• Pay: $190500–$260000 yearly
• Team: Leads a Clinical Operations study team with multiple direct reports (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates); interfaces with Medical Directors and cross-functional teams.
• Mission: Oversee the strategic planning and operational execution of Neurocrine’s clinical studies from all phases to achieve program objectives and corporate goals.

What You’ll Actually Do
• Strategy: Design and implement clinical strategies by effectively utilizing both internal and external resources.
• Execution: Lead the tactical implementation and execution of the clinical development process across all phases, primarily for selected programs.
• Budget Management: Establish and manage overall clinical program budgets, including individual study budgets, to ensure financial oversight.
• Vendor Oversight: Manage relationships and expectations with CROs and other clinical contract service providers, acting as the primary point of contact with these external bodies.
• Team Leadership: Recruit, train, and manage the career development of multiple direct reports within the clinical operations group, fostering a high-performing team.

The Must-Haves
• Background: Bachelor’s degree in a scientific or related field, or a Master’s degree or MBA in a scientific or related field.
• Experience: 12+ years of extensive, progressively responsible experience in clinical research within the pharmaceutical/biotech industry or a CRO, or 10+ years with a Master’s/MBA. This includes extensive prior managerial experience and expertise directing global studies, particularly in endocrine-related indications and/or rare diseases.
• Skills: Detailed knowledge of the clinical drug development process, including ICH, GCPs, FDA regulations, and EU directives. Proven ability to effectively manage, mentor, and train personnel, along with strategic vendor management skills, especially with CROs. Strong organizational, interpersonal, leadership, and negotiation/influencing skills are essential for this role.