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.

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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Drives the strategic scientific direction for assigned programs and other areas of responsibility

• Leads the design, conduct, interpretation and timely reporting of Safety Pharmacology and Toxicology studies/data for assigned programs

• Ensures regulatory Toxicology responsibilities are aligned with portfolio priorities and timely completion of all assignments

• Manages studies at preclinical Contract Research Organizations (CROs) for assigned programs

• Critically evaluate toxicology and safety pharmacology results, assess potential impact, communicate findings to management and provide strategic advice to project teams and senior management on potential impact of toxicology results on Program and Clinical/Regulatory strategy

• Authors and reviews pharmacology and toxicology summaries for clinical and regulatory documents (IB, IND, CTA, NDA, briefing books, Investigator Brochures, periodic safety reports, etc.)

• Represents Preclinical Development on discovery and development teams

• Regularly interfaces with internal and external scientists to ensure timely and accurate dissemination of nonclinical safety study results to peers, program teams and Neurocrine Management

• Contribute to the preparation of SOPs as needed to guide functional activities

• Oversees the adherence of regulatory toxicologists to all Toxicology SOPs

• Knowledgeable of current regulatory guidance (eg ICH, EMA, FDA) related to preclinical development

• Manages junior members of department

• Other tasks as assigned

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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.

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