Principal Scientist/Sr. Principal Scientist, Toxicology

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.

What We Do:

Neurocrine Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

As a scientific leader, will develop and lead Toxicology/Safety Pharmacology projects, and oversee studies from planning through to final reporting. Participates in formulating the strategic and operational direction of the function ensuring all studies are conducted in line and adhere to appropriate guidelines and regulatory testing standards and individual program objectives. Recommend scientific strategies for overall programs and/or department. Represents Toxicology on Development teams and may advise senior technical leadership of Toxicology/Safety pharmacology findings and recommendations

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

• Participates in formulating toxicology strategies and leads the execution in order to develop and implement plans for nonclinical safety testing of new and current drug candidates

• Designs, evaluates and implements protocol preparation for assigned Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports

• Continuously performs extensive analyses/interpretations of Toxicology/Safety Pharmacology data, prepares clear technical reports and oral presentations, and serves as a key opinion leader(s) making a go/no-go decision

• Authors and/or reviews Toxicology/Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA (BLA)/MAA submissions

• Owns preparation of documents and annual investigational new drug and new drug application reports

• Independently performs quality control checks on Toxicology/Safety Pharmacology documents for regulatory submission

• Drives the identification, evaluation, selection and management Toxicology/Safety Pharmacology CROs, act as technical expert and ensure CROs have sufficient capabilities, resources to executes against contractual obligations

• Proactively recommends and dr