Sr. Scientific Director, Toxicologic Pathology

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 , and follow the company on Linked In,Xand Facebook.

About the Role:

As a Sr. Leader, serves as the lead for Nonclinical Safety (anatomic and clinical pathology & toxicology) of multiple drug candidates of NBI's pipeline. Acts as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies to ensure high-quality toxicology and pathology assessments. Provides comprehensive support for nonclinical studies, including primary histopathology and pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA, briefing books, Investigator Brochures, etc.).

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. Demonstrates excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams.

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

• Serve as the lead for Nonclinical Safety (anatomic and clinical pathology & toxicology), shaping the strategy and execution of nonclinical safety assessments for NBI's pipeline

• Provide comprehensive support for nonclinical studies, including but not limited to pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions

• Act as the Principal Investigator for pathology components of non-GLP and GLP-compliant studies and communicate effectively with CRO pathologists to discuss findings, address questions, and reach the pathology conclusions to ensure high-quality toxicology and pathology assessments

• Manage and provide scientific leadership to the internal staff and work closely with Discovery, Preclinical and Clinical Pharmacology (PCCP), Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals

• Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)

• Represent Preclinical Development on discovery and development-stage program teams

• Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to all Toxicology and Pathology SOPs

• Maintain current knowledge of regulatory guidance, industry standards and recommendations

• Participates in selecting, developing and evaluating personnel to ensure efficient operation within the toxicology group

• Other pathology-related tasks as assigned

Requirements:

• DVM and/or PhD with specialty training and experience in toxicologic pathology…