Director, Clinical Operations

Neurocrine Biosciences; San Diego (CA); Vor Ort; USD 190.500 - 260.000; Vollzeit

Benefits dieser Stelle

Competitive base salary

Annual bonus 35% targeting

Equity long-term incentive

Comprehensive health benefits

Zusammenfassung

Neurocrine Biosciences in San Diego is seeking a Director of Clinical Operations to develop and oversee strategic plans for clinical studies across all phases. You will ensure regulatory compliance, budget adherence, and successful collaboration with CROs, vendors, and internal stakeholders to achieve program goals.

The role requires extensive experience in clinical drug development, global trial management, and leadership of diverse teams in biotech/pharma settings.

Qualifikationen

• Knowledge of ICH, GCPs, FDA regulations and EU directives.
• Experience directing global studies, esp. endocrine/rare diseases.
• Ability to lead and mentor personnel; strong negotiation skills.

Aufgaben

• Design and oversee clinical strategies using internal and external resources.
• Lead the Clinical Operations study team and mentor staff.
• Oversee CROs, vendors, and timelines to meet program goals.
• Ensure studies comply with FDA, EU guidelines, ICH SOPs.
• Manage program budgets and study budgets.
• Collaborate with Regulatory, QA, and Medical.

Kenntnisse

Clinical Operations leadership

CRO/vendor management

FDA regulations

ICH guidelines

GCPs

Global study management

Budget & forecasting

Team leadership

Project management

Strategic planning

Ausbildung

BS/BA degree in scientific field

MS/MBA with clinical research experience

12+ years in pharma/biotech clinical operations

Jobbeschreibung

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are 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 for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie) At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

About the Role

Responsible for developing strategic plans, objectives and overall management for 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 are in adherence with corporate and departmental Standard Operations Procedures. A key focus will be on the oversight of CROs, external vendors and internal stakeholders to ensure studies are conducted according to timelines, budgets, and resources to achieve program objectives and corporate goals. The Director will also manage career development of multiple direct reports within clinical operations group.

Your Contributions

• Design and implement clinical strategies using internal and external resources
• Provides 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 these activities are conducted in compliance with FDA regulations, EU Directive and ICH guidelines, and are in adherence with corporate and departmental Standard Operating Procedures (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 to develop and revise performance to reach and maintain highest possible standards of excellence
• Identify and introduce process improvements within 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 adequate support for clinical programs as well as provide input into cross functional meetings and documentation
• Interface with Medical Directors by providing operational input to clinical protocols, clinical development plans and clinical 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 with traditional progression in clinical research in pharmaceutical/biotech industry, or CRO or relevant experience required.
• Experience in clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive also required.
• Prior experience directing global studies, particularly in endocrine related indications and/or rare diseases.
• OR Master's degree in scientific or related field or MBA AND 10+ years of similar experience shown above.
• OR Extensive previous managerial experiences also required Detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, FDA regulations and EU directive.
• Ability to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goals Expertise directing global studies, particularly in endocrine related indications and/or rare diseases Strategic vendor management skills, particularly CROs or similar complexity Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact Ability to work independently and cooperate and collaborate with a wide variety of individuals, groups, and teams Ability to effectively operate in a multi-level matrix environment Strong organizational, interpersonal and leadership skills Strong internal/external negotiation / influencing skills

Benefits

• The annual base salary we reasonably expect to pay is $190,500.00-$260,000.00.
• Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
• In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program.
• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2025. We were also named a Great Place to Work Certified company.

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements.

OUR VALUES

• PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
• INNOVATION: We seek and create optimal solutions.
• TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!