Sr. Director/Executive Director MD, Immunology Clinical Development

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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Drives strategic organizational plans and policies for clinical trials/research and data collection activities in diseases associated with dysfunction of the immune system (including but not limited to rheumatological, dermatological, GI or CNS disorders). Works with a multidisciplinary team involving R & D project teams, clinical project managers, business management, regulatory, and others to design and execute clinical plans and clinical trials. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiate study design. Responsible for overseeing human clinical trials, phases I – IV, from a clinical perspective, for company products under development. These responsibilities include monitoring trial participant safety and quality of execution of trial by study sites. In addition, this role coordinates and develops information for reports submitted to regulatory or other agencies. The role involves cross-functional leadership and collaboration with regulatory, new product commercialization, clinical operations, medical affairs, pharmacovigilance, legal or other functions to deliver cross-functional projects where clinical data or assessment of medical needs play a critical role.

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Your Contributions (include, but are not limited to):

• Drive strategic direction for organizational plans and policies for clinical trials/research and data collection activities. Responsible for the implementation of clinical projects

• Create and foster strong relationships with investigators

• Collaborates with senior management in the development of strategies, research plans, budgets, and clinical summaries

• Monitor adherence to protocols

• Supervise the organization of monitoring procedures and collection of data

• Synthesize study-related data from multiple sources to drive study/program strategy

• Monitor clinical trials directly and indirectly through assigned CRAs and CROs

• Provide necessary input for Investigator Brochures and FDA documents including IND and NDA documents

• Collaborate on multidisciplinary project teams to deliver development goals

• Participate in and speak at professional meetings

• Provide clinical assessment or interpretation of data or literature in the preparation of  final study reports, other regulatory documents or scientific publications

• Anticipate factors that could impact Neurocrine’s strategies and its position in the field and recommend new or innovative solutions

• Direct the development of protocols and study designs

• Select, develop and evaluate clinical department personnel to ensure the efficient operation of the function

• Other duties as assign