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.
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Your Contributions (include, but are not limited to):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
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
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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. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
