Neurocrine Biosciences · 3 days ago
Sr. Scientific Director, Toxicologic Pathology
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological disorders. The Sr. Scientific Director, Toxicologic Pathology will act as the Principal Investigator for pathology components of studies, ensuring high-quality toxicology assessments and providing comprehensive support for nonclinical studies.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
DVM or PhD and 10+ years of industry experience in toxicologic pathology within biotech or pharmaceutical settings
Board Certification by the American College of Veterinary Pathologists (ACVP) is required
Expert knowledge in nonclinical safety assessment in drug development of small molecules, biologics, and peptides. Knowledge in gene therapy is plus
Strong experience of designing, overseeing, and interpreting GLP and non-GLP toxicology studies
Demonstrate ability to lead and manage internal team members, consultants, and CRO partnerships
Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities
Experience in responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs
Expertise with the design and management of safety pharmacology and toxicology studies (GLP and non-GLP) supporting nonclinical and clinical development programs
Excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams
Proven ability to thrive in a fast-paced, biotech environment
Benefits
Annual bonus with a target of 35% of the earned base salary
Eligibility to participate in our equity based long term incentive program
Retirement savings plan (with company match)
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Recent News
2026-01-06
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