Toxicology Operations Manager

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

Performs day-to-day contract-related activities for Toxicology and Safety Pharmacology studies. Works with preclinical Contract Research Organizations (CROs) to schedule studies to support the discovery and development of the Company’s compounds. Coordinates study archiving activities at various CROs. Coordinates domestic and international Test Article (TA) shipments. Reviews and approves invoices for study and archiving activities. Works with Toxicology Program leads (TPLs) and provide operational support and directions. Monitors toxicology studies and assist in selection and qualification of preclinical CROs as needed. Performs QC on Toxicology and Safety Pharmacology sections of regulatory documents as needed.

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

• Performs day-to-day operational and contractual activities supporting Toxicology and Safety Pharmacology studies, ensuring alignment with project timelines, departmental objectives, and business priorities
• Assists in the selection, qualification, and ongoing management of preclinical Contract Research Organizations (CROs), including evaluating vendor capabilities, performance, and operational effectiveness
• Assists 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
• Collaborates 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
• Manages CRO-related contracts, study budgets, and operational resources, monitoring expenditures and identifying opportunities to improve cost efficiency and vendor performance
• Assists the development, review, and implementation of Standard Operating Procedures (SOPs) and operational processes within the Preclinical and Clinical Pharmacology (PCCP) 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

Requirements:

• BS degree in Toxicology or related field and 6+ years of experience in biotech, pharmaceutical industry and/or CRO with emphasis on Toxicology OR
• MS degree in Toxicology or related field and 4+ years of experience in biotech, pharmaceutical industry and/or CRO with emphasis on Toxicology
• Expertise in placing and monitoring Toxicology and Safety Pharmacology studies at preclinical CROs
• Ability to work cross-functionally to ensure operational activities associated with Toxicology and Safety Pharmacology studies are successfully executed
• Proactive to identify and resolve operational problems efficiently
• Strong understanding of CRO selection, qualification, vendor management, and study oversight processes to ensure quality, timelines, and deliverables are met
• Demonstrated ability to address operational challenges.Experience managing CRO contracts, study budgets, and vendor relationships to support efficient and cost-effective study execution
• Strong organizational, planning, and project management skills, with the ability to manage multiple priorities, timelines, and deliverables effectively
• Strong analytical and problem-solving skills, with the ability to evaluate complex operational challenges, exercise sound judgment, and recommend effective solutions

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