Toxicology Operations Manager
About The Position
The Toxicology Operations Manager performs day-to-day contract-related and operational activities for Toxicology and Safety Pharmacology studies. The role works with preclinical Contract Research Organizations (CROs) to schedule, place, coordinate, and monitor studies supporting discovery and development of the company’s compounds. It coordinates study archiving and domestic and international Test Article shipments, reviews and approves invoices, and provides operational support and direction to Toxicology Program leads. The position also supports CRO selection, qualification, and ongoing oversight; manages CRO contracts, study budgets, and operational resources; and helps maintain study quality, timelines, and deliverables. The manager assists with SOPs and operational processes 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. The role identifies process improvements and collaborates with internal stakeholders and CRO partners.
Requirements
- Bachelor’s degree in Toxicology or a related field and at least 6 years of experience in biotech, the pharmaceutical industry, and/or a CRO with emphasis on Toxicology; or a Master’s 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 execute operational activities for Toxicology and Safety Pharmacology studies.
- 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.
- Ability to collaborate across functions, build productive relationships, and influence outcomes.
- Strong attention to detail, accuracy, and quality, with an ability to identify process improvements and operational efficiencies.
Responsibilities
- Perform day-to-day operational and contractual activities supporting Toxicology and Safety Pharmacology studies, aligned with project timelines, departmental objectives, and business priorities.
- Assist in selecting, qualifying, and managing preclinical CROs, including evaluating vendor capabilities, performance, and operational effectiveness.
- Coordinate placement and execution of Toxicology and Safety Pharmacology studies at CROs, including pre-study planning, monitoring, and resolution of operational challenges.
- Collaborate with internal stakeholders and CRO partners to support 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 developing, reviewing, and implementing 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
