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:

Responsible for supporting the execution of IND Operations within Preclinical Development. Contributes to cross-functional teams that design and conduct nonclinical studies required to enable First-in-Human (FIH) studies for Neurocrine clinical development candidates.

Collaborates with internal stakeholders including Research, CMC, ADME, Toxicology, Regulatory, Biomarker, Project Management, and Clinical to ensure timely progression of development programs. Supports implementation of development strategies, coordinates study activities, and ensures deliverables are completed in alignment with established timelines and quality expectations.

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

• Execute IND-enabling operational plans for assigned development programs in alignment with established strategy and timelines

• Coordinate cross-functional activities required for nonclinical studies and regulatory deliverables (e.g., IND/CTA sections)

• Collaborate with functional representatives to develop study timelines, roles, and responsibilities

• Track progress of studies and deliverables; identify risks and escalate issues as appropriate

• Contribute to the preparation, coordination, and review of regulatory documents (INDs, CTAs, and supporting sections)

• Manage multiple concurrent activities while balancing priorities to ensure timely and high-quality deliverables

• Maintain working knowledge of current regulatory guidance relevant to IND-enabling activities

• May mentor junior staff or lead discrete workstreams within a program

• Perform other duties as assigned

Requirements:

• PhD in Pharmacokinetics, Pharmaceutical Sciences, or a related discipline and 1+ years of relevant pharmaceutical/biotech experience OR

• Master’s degree with 4+ years of relevant experience OR

• Bachelor’s degree with 6+ years of relevant experience

• Prior experience in preclinical development and IND-enabling activities preferred

• Some project leadership or functional management experience preferred

• Working knowledge of regulatory requirements for IND/CTA submissions

• Familiarity with preparation of regulatory submission components

• Ability to identify risks and support development of mitigation strategies

• Working knowledge of preclinical drug development processes, including Pharmacology, ADME, Toxicology, and CMC components supporting IND-enabling activities

• Ability to analyze issues of moderate complexity and recommend effective solutions within established frameworks

• Demonstrated ability to manage multiple activities or projects simultaneously while maintaining quality and timelines

• Effective collaboration and communication skills in a cross-functional, matrixed environment

• Ability to influence team members and build alignment across functions

• Strong organizational, problem-solving, and project management skills

• Proactive, detail-oriented, and able to adapt to shifting priorities

#LI-LS1

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.

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The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. 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.