Director, Clinical Operations

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline of compounds in mid- to late-phase clinical development. For over three decades, Neurocrine has applied unique insights into neuroscience and interconnected body systems to address complex conditions.

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 comply with FDA regulations, EU Directive, ICH guidelines, and adhere to corporate and departmental Standard Operating Procedures (SOPs). Oversee CROs, external vendors, and internal stakeholders to ensure studies are conducted according to timelines, budgets, and resources to achieve program objectives and corporate goals. Manage career development for multiple direct reports within the clinical operations group.

• Design and implement clinical strategies using internal and external resources
• Provide leadership to the Clinical Operations study team (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees)
• Lead the tactical implementation and execution of the clinical development process (all phases) primarily for selected programs
• Ensure compliance with FDA regulations, EU Directive, ICH guidelines, and corporate/departmental SOPs
• Establish and manage overall clinical program budgets as well as individual study budgets
• Develop and maintain clinical trial timelines to achieve corporate goals
• Create and establish critical metrics to benchmark activities and revise performance standards
• Identify and introduce process improvements within the clinical organization
• Manage relationships and expectations with CROs and other clinical contract service providers; act as point of contact with external bodies
• Manage inter-department relationships (Regulatory, QA, etc.) to ensure support for clinical programs
• Interface with Medical Directors by providing operational input to clinical protocols, development plans, and study reports
• Recruit, train, and manage career development of multiple direct reports within the clinical operations group
• Manage operational activities of clinical programs with corporate partners
• Perform additional tasks and duties as assigned

Requirements

• BS/BA degree in scientific or related field AND 12+ years of extensive experience in clinical research within the pharmaceutical/biotech industry, CRO, or relevant experience
• OR Master’s degree in scientific or related field or MBA AND 10+ years of similar experience
• Experience in clinical drug development process, including working knowledge of ICH, GCPs, FDA regulations, and EU directive
• Prior experience directing global studies, particularly in endocrine-related indications and/or rare diseases
• Extensive previous managerial experience
• Ability to effectively manage, mentor, and train personnel to achieve goals
• Strategic vendor management skills, particularly with CROs or similar complexity
• Recognized as an internal thought leader with extensive technical and business expertise
• Applies in-depth knowledge to solve critical issues innovatively
• Evaluates key business/scientific challenges and completes complex initiatives with cross-functional impact
• Ability to work independently and collaborate with diverse individuals, groups, and teams
• Strong organizational, interpersonal, leadership, negotiation, and influencing skills

Pay

The annual base salary range is $190,500.00–$260,000.00. Individual pay decisions depend on factors such as primary work location, role complexity, job duties, and relevant experience. This position also offers an annual bonus with a target of 35% of the earned base salary and eligibility for an equity-based long-term incentive program.

Benefits

• Retirement savings plan with company match
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage