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 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, 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.
Your Contributions (include, but are not limited to): Your Contributions (include, but are not limited to): - 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
Requirements: - 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
Preferred Skills - DABT certification preferred
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Requirements: 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.
The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. 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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