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.

What We Do:

Neurocrine Biosciences is a leading neurosciencefocused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing lifechanging treatments for patients with underaddressed neurological, neuroendocrine and neuropsychiatric disorders. The companys diverse portfolio includes FDAapproved treatments for tardive dyskinesia, chorea associated with Huntingtons disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid to latephase 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:

Key role in the discovery and development of Neurocrines 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 are not limited to):

• Develops and implements plans for preclinical testing of new and current drug candidates
• Selects and manages Toxicology and Safety Pharmacology CROs
• Oversees 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 prestudy activities, and approving study protocols and reports
• Performs thorough analyses/interpretations of Toxicology/Safety Pharmacology data and participates in go/nogo decision making
• Prepares SOPs as needed to guide the Toxicology and Safety Pharmacology programs
• Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions
• Keeps uptodate with current regulatory guidance
• Collects, analyzes, interprets complex data, communicates results, and writes reports in a timely manner
• Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams
• Performs quality control checks on nonclinical pharmacology and toxicology documents for regulatory submission
• Assists in the preparation of documents and annual investigational new drug and new drug application reports
• May provide support to build and maintain technical databases, archives and department procedures manuals
• May lead lower level scientists and/or project teams
• Other duties as assigned

Requirements:

• BS/BA in Toxicology, Pharmacology, Biology or related discipline required and 12+ years of CRO and/or pharmaceutical industry experience. Experience in small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies. Technical leadership experience in managing preclinical Contract Research Organizations. Experience with preparation of INDs, CTDs, NDAs, and MAAs OR
• MS/MA degree Toxicology or related field AND 10+ years of similar experience as note above OR
• PhD in Toxicology or related field preferred AND 4+ years of relevant experience; may include postdoc experience OR
• DABT certification is desirable AND
• Assimilates data and research findings outside of Neurocrine for application to new scientific projects
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
• May develop an understanding of other areas and related dependencies
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
• Knowledge of preparation of INDs, CTDs, NDAs, and MAAs
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Sees broader picture, impact on multiple programs, teams and/or departments
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Proactive, innovative, with good problemsolving skills
• Excellent written, presentation, and verbal communication skills

LIDM1

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 dont line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $166,600.00$185,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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