Associate Scientific Director, Toxicology

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Lead toxicology strategy and execution for new and existing drug candidates

• Design, evaluate, and manage Toxicology and Safety Pharmacology studies, including protocol development, budgeting, oversight, and reporting

• Analyze and interpret study data; prepare technical reports and oral presentations for internal key stakeholders

• Own preparation and quality control of regulatory documents (IB, IND, CTA, NDA/BLA), including annual updates and submissions

• Recommend and implement process improvements and SOP updates to optimize program efficiency

• Stay current with global regulatory guidance and proactively inform stakeholders

• Collaborate across multidisciplinary teams and support technical documentation and database management

• Mentor junior scientists, and lead/contribute to intellectual property development

• Lead the development of intellectual property

• Support additional strategic initiatives as needed

• BS/BA in Toxicology, Pharmacology, Biology, or related discipline with 15+ years of experience of CRO and/or pharmaceutical industry experience, including Safety Pharmacology OR

• MS/MA with 13+ years OR

• PhD with 7+ years in similar fields and roles

• Extensive experience in Safety Pharmacology, Toxicology, and Pathology across small molecules, peptides, and biologics (gene therapy knowledge a plus)

• Proven leadership in managing preclinical CROs and regulatory submissions (IB, IND, CTA, NDA/BLA/MAA)

• Strong knowledge of ICH and FDA guidance

• DABT certification preferred

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, 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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