Toxicology Operations Lead: CRO & Study Coordination

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Neurocrine Biosciences, Inc. is seeking a senior professional to perform day-to-day contract activities for Toxicology and Safety Pharmacology studies. The role coordinates CROs, reviews invoices, and supports study oversight from preclinical through regulatory documentation.

You will work with TPLs and drive operational improvements within PCCP. The position requires a BS or MS in Toxicology with 4–6+ years of industry/CRO experience, strong vendor management, and cross-functional

Qualifications

• BS degree in Toxicology or related field with 6+ years' biotech/CRO experience.
• MS degree with 4+ years' Toxicology experience accepted.
• Expertise in placing and monitoring Toxicology and Safety Pharmacology studies at preclinical CROs.
• Strong cross-functional collaboration and vendor management.

Responsibilities

• Coordinate day-to-day contract activities for Toxicology and Safety Pharmacology studies.
• Assist in the selection, qualification, and ongoing management of preclinical CROs, including evaluating vendor capabilities, performance, and operational effectiveness.
• Assist in the placement and operational coordination of Toxicology and Safety Pharmacology studies at CROs, including pre-study planning, study monitoring, and resolution of operational challenges.
• Collaborate with internal stakeholders and external CRO partners to ensure effective study execution, proactively identify risks, and recommend solutions to maintain study quality, timelines, and deliverables.
• Manage CRO-related contracts, study budgets, and operational resources, monitoring expenditures and identifying opportunities to improve cost efficiency and vendor performance.
• Assist the development, review, and implementation of SOPs and operational processes within the Preclinical and Clinical Pharmacology department to support consistency, compliance, and continuous improvement.
• Coordinates and performs quality control reviews of Toxicology and Safety Pharmacology sections of regulatory documents, including INDs, CTAs, IBs, annual reports, and NDA/BLA/MAA submissions, ensuring accuracy, completeness, and consistency.
• Helps identify and implements improvements to study management processes, vendor oversight practices, and cross-functional workflows to enhance operational efficiency and effectiveness.
• Other duties as assigned

Skills

Vendor management

Project management

Regulatory QC

Operational excellence

Communication skills

Education

BS in Toxicology

MS in Toxicology

Job description

Neurocrine Biosciences, Inc. is seeking a senior professional to perform day-to-day contract activities for Toxicology and Safety Pharmacology studies. The role coordinates CROs, reviews invoices, and supports study oversight from preclinical through regulatory documentation.

You will work with TPLs and drive operational improvements within PCCP. The position requires a BS or MS in Toxicology with 4–6+ years of industry/CRO experience, strong vendor management, and cross-functional