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

About the Role:

Responsible for overseeing the design, conduct, interpretation and reporting of Safety Pharmacology and Toxicology studies for assigned Discovery and Development programs. Collaborates with preclinical colleagues to develop overall Safety Pharmacology and Toxicology Development Strategies for assigned programs. Represents Preclinical Development on Discovery and Development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings. Authors and reviews regulatory submissions and meets with Health Authorities to support clinical trials of Neurocrine development candidates from initiation of First in Human to phase 3 clinical trials and marketing applications.

1. Drives the strategic scientific direction for assigned programs and other areas of responsibility
2. Leads the design, conduct, interpretation and timely reporting of Safety Pharmacology and Toxicology studies/data for assigned programs
3. Ensures regulatory Toxicology responsibilities are aligned with portfolio priorities and timely completion of all assignments
4. Manages studies at preclinical Contract Research Organizations (CROs) for assigned programs
5. Critically evaluates toxicology and safety pharmacology results, assesses potential impact, communicates findings to management and provides strategic advice to project teams and senior management on potential impact of toxicology results on Program and Clinical/Regulatory strategy
6. Authors and reviews pharmacology and toxicology summaries for clinical and regulatory documents (IB, IND, CTA, NDA, briefing books, Investigator Brochures, periodic safety reports, etc.)
7. Represents Preclinical Development on discovery and development teams
8. Regularly interfaces with internal and external scientists to ensure timely and accurate dissemination of nonclinical safety study results to peers, program teams and Neurocrine Management
9. Contributes to the preparation of SOPs as needed to guide functional activities
10. Oversees the adherence of regulatory toxicologists to all Toxicology SOPs
11. Knowledgeable of current regulatory guidance (eg ICH, EMA, FDA) related to preclinical development
12. Manages junior members of department
13. Other tasks as assigned

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.

The annual base salary we reasonably expect to pay is $177,100.00-$256,350.00. 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 35% 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.