Director, Clinical Operations
Neurocrine BiosciencesAbout the role
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)
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 (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
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