Toxicology Operations Manager
About The Position
Neurocrine Biosciences is a biopharmaceutical company focused on discovering, developing, and commercializing treatments for neurological, psychiatric, endocrine, and immunological disorders. The Toxicology Operations Manager performs day-to-day contractual and operational activities for Toxicology and Safety Pharmacology studies, working with preclinical Contract Research Organizations (CROs) to schedule and support studies for the discovery and development of company compounds. The role coordinates study archiving and domestic and international Test Article shipments, reviews and approves invoices, and provides operational support and direction to Toxicology Program leads. It also monitors studies, supports CRO selection and qualification, and performs quality-control reviews of relevant regulatory-document sections. The position supports study execution from planning through monitoring, CRO and vendor oversight, contract and budget management, operational risk resolution, and process improvement. It collaborates with internal stakeholders and CRO partners to maintain study quality, timelines, and deliverables. The role also contributes to SOPs and operational processes in the Preclinical and Clinical Pharmacology department and reviews Toxicology and Safety Pharmacology content in regulatory submissions and reports.
Requirements
- Bachelor of Science degree in Toxicology or a related field and at least 6 years of experience in biotech, the pharmaceutical industry, and/or a CRO with an emphasis on Toxicology; alternatively, a Master of Science degree in Toxicology or a related field and at least 4 years of such experience.
- Expertise placing and monitoring Toxicology and Safety Pharmacology studies at preclinical CROs.
- Ability to work cross-functionally to ensure operational activities for Toxicology and Safety Pharmacology studies are successfully executed.
- Proactive approach to identifying and efficiently resolving operational problems.
- Strong understanding of CRO selection, qualification, vendor management, and study-oversight processes.
- Experience managing CRO contracts, study budgets, and vendor relationships.
- Strong organizational, planning, and project-management skills, including the ability to manage multiple priorities, timelines, and deliverables.
- Strong analytical and problem-solving skills, sound judgment, and ability to recommend effective solutions to complex operational challenges.
- Excellent written, verbal, and interpersonal communication skills for collaborating with internal and external stakeholders.
- Demonstrated ability to build productive cross-functional relationships and influence outcomes.
- Strong attention to detail, accuracy, and quality, and ability to identify opportunities for process improvement and operational efficiency.
Responsibilities
- Perform day-to-day operational and contractual activities supporting Toxicology and Safety Pharmacology studies, aligning work with project timelines, departmental objectives, and business priorities.
- Assist with selection, qualification, and ongoing management of preclinical CROs, including evaluation of vendor capabilities, performance, and operational effectiveness.
- Assist with 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 CRO partners to support effective study execution, identify risks, and recommend solutions that maintain study quality, timelines, and deliverables.
- Manage CRO-related contracts, study budgets, and operational resources; monitor expenditures and identify opportunities to improve cost efficiency and vendor performance.
- Assist with the development, review, and implementation of SOPs and operational processes in the Preclinical and Clinical Pharmacology department.
- Coordinate and perform quality-control reviews of Toxicology and Safety Pharmacology sections of regulatory documents, including INDs, CTAs, IBs, annual reports, and NDA/BLA/MAA submissions.
- Identify and implement improvements to study-management processes, vendor-oversight practices, and cross-functional workflows.
- Coordinate study archiving activities at CROs and domestic and international Test Article shipments.
- Review and approve invoices for study and archiving activities.
- Provide operational support and direction to Toxicology Program leads.
- Perform other duties as assigned.
Benefits
- Annual bonus with a target of 30% of earned base salary.
- Eligibility to participate in an equity-based long-term incentive program.
- Retirement savings plan with company match.
- Paid vacation, holidays, and personal days.
- Paid caregiver/parental and medical leave.
- Medical, prescription drug, dental, and vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
