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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• Develops, implements and directs toxicology strategies to support assigned discovery and development programs

• Supports planning and execution of Safety Pharmacology and Toxicology studies/data for all programs

• Oversees and directs assignments within the regulatory Toxicology function to ensure timely completion of priority activities

• Evaluate, interpret and summarize toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy

• Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)

• Represent Preclinical Development on discovery and development-stage program teams

• Provides strategic oversight and direction for the preparation of data summaries and contributes to the presentation of results to peers, colleagues and Neurocrine Management

• Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to SOPs

• Oversees the adherence of regulatory toxicologists to all Toxicology SOPs

• Maintain current knowledge of regulatory guidance, industry standards and recommendations

• Participates in the selecting, developing and evaluating personnel to ensure the efficient operation within the toxicology group

• Other tasks as assigned

• PhD in Toxicology, Pathology or closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations.

• Exhibits ability to become company-wide advisor and emerging industry expert

• Demonstrated strategy development and implementation within areas of responsibility

• Possesses expert knowledge of own function and broad knowledge of multiple functions and impact on business

• Proven leadership skills and ability, including influencing across many levels of the organization

• Expert knowledge of drug development strategies for various modalities including small molecules, biologics, therapeutic peptides, therapeutic areas (including neuroscience and endocrinology) and regulatory regions including US, Canada, Europe and Japan

• Expert knowledge of managing clinical Contract Research Organizations (CRO's)

• Demonstrated experience in the of preparation of INDs, CTAs, NDAs, and MAAs

• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas

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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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