Sr. Director, Clinical Operations

Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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

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- (_*in collaboration with AbbVie_)

About the Role:
Responsible for developing strategic and operational plans for Clinical Operations. Develops broader functional strategy development with senior leadership and peers across the organization. Makes decisions for area of responsibility and ensures the effective achievement of objectives and overall management for Clinical Operations team executing Neurocrine's clinical studies (all phases). Ensures 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. Manages the career development of multiple direct reports within the Clinical Operations group.

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Your Contributions (include, but are not limited to):
- Develops broader functional strategy in collaboration with Clinical Operations and other senior leadership- Provides leadership to the Clinical Operations study team (Associate Directors, Clinical Trial Managers, Specialists, Clinical Trial Associates, and other subordinate employees)- Leads the tactical implementation and execution of the clinical development process (all phases) primarily for selected programs.- Accountable for multiple sub-function(s)- Ensures 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)- Establishes and manages overall clinical program budgets as well as individual study budgets with additional oversight responsibility of contractor, vendor, and CRO budgets- Develops and maintains clinical trial timelines to achieve corporate goals.- Creates and establishes critical metrics to benchmark activities to develop and revise performance to reach and maintain highest possible standards of excellence- Working with other functional area representatives (e.g., Clinical QA, Clinical Compliance) identifies and introduces process improvements within clinical organization- In collaboration with Clinical Outsourcing, manages relationships and expectations with CROs and other clinical contract service providers. Act as point of contact with external bodies- Manages 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 Clinical Development by providing operational input to clinical protocols, clinical development plans and clinical study reports- Recruits, trains, and manages career development of multiple direct reports within the Clinical Operations group- Manages operational activities of clinical programs with corporate partners.- Performs additional tasks and duties as assigned

Requirements:
- BS/BA degree and 15+ years of relevant experience 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- Masters degree and 13+ years of similar experience shown above OR- PhD and 10+ years of similar experience shown above. Extensive previous ma