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Principal Scientist, Toxicology

Neurocrine Biosciences, Inc. - San Diego, CA

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Job Description

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 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, endocrine and psychiatric disorders. The company''s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson''s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVieAbout the Role:Key role in the discovery and development of Neurocrine''s development compounds. Working with Neurocrine colleagues, participates in all stages of Toxicology/Safety Pharmacology assessment, from study planning through to regulatory submission. Will have expertise in either or both study management/oversight or interpretation of study results. Provides strategic and operations direction ensuring all studies are conducted in line with appropriate guidelines and regulatory testing standards and individual program objectives. May represent Toxicology on Development teams and regularly interfaces with colleagues to ensure timely study conduct and/or rapid and accurate dissemination of Toxicology/Safety pharmacology findings.Your Contributions (include, but not limited to):Develops and implements plans for preclinical testing of new and current drug candidatesSelects and manages Toxicology and Safety Pharmacology CROsOversees and leads protocol preparation for 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 reportsPerforms thorough analyses/interpretations of Toxicology/Safety Pharmacology data and participates in go/no-go decision makingPrepares SOPs as needed to guide the Toxicology and Safety Pharmacology programsAuthors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissionsKeeps up-to-date with current regulatory guidanceCollects, analyzes, interprets complex data, communicates results, and writes reports in a timely mannerWorks collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teamsPerforms quality control checks on non-clinical pharmacology and toxicology documents for regulatory submissionAssists in the preparation of documents and annual investigational new drug and new drug application reportsMay provide support to build and maintain technical databases, archives and department procedures manualsMay lead lower level scientists and/or project teamsOther duties as assignedRequirements:Bachelors degree in life sciences or related field and 12+ years of experience in CRO and/or pharmaceutical industry in the conduct and/or oversight of small molecule Toxicology/Safety Pharmacology programs. Experience in managing preclinical Contract Research Organizations. Experience working in a cross functional team and matrix environment. Experience with preparation of INDs, CTDs, NDAs, and MAAs preferred ORMS/MA degree Toxicology or related field and 10+ years of similar experience as note above ORPhD in Toxicology or related field preferred and 4+ years of relevant experience; may include postdoc experienceDABT certification is desirableAssimilates data and research findings outside of Neurocrine for application to new scientific projectsMaintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areasMay develop an understanding of other areas and related dependenciesAdvanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/toolsKnowledge of preparation of INDs, CTDs, NDAs, and MAAsAbility to work as part of and lead multiple teamsExhibits leadership skill and ability, typically leads lower levels and/or indirect teamsExcellent computer skillsSees broader picture, impact on multiple programs, teams and/or departmentsAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management skillsProactive, innovative, with good problem-solving skillsExcellent written, presentation, and verbal communication skillsLI-DM1Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.As a condition of employment with Neurocrine Biosciences, Inc. in the United States, you must be fully vaccinated for COVID-19 and provide valid proof of vaccination to the company.

Created: 2026-04-04

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