Our client is seeking an experienced Toxicology Operations specialist to support the planning, coordination, execution, and oversight of nonclinical toxicology studies that advance drug development programs from early research through regulatory submission and lifecycle support. This individual will work closely with cross-functional teams and external research partners to ensure studies are executed with scientific rigor, regulatory compliance, and operational excellence.
The successful candidate will serve as a key liaison between internal stakeholders and contract research organizations (CROs), helping manage study execution, timelines, data review, and reporting while contributing to continuous process improvement across the toxicology function.
Scientific Responsibilities
• Coordinate communications with CRO study directors, principal investigators, and scientific staff throughout the lifecycle of toxicology studies.
• Review study protocols, amendments, deviations, draft reports, and supporting documentation for scientific quality, completeness, and consistency.
• Compile, organize, and evaluate toxicology data to identify trends, discrepancies, or findings requiring further scientific assessment.
• Prepare data summaries, figures, tables, and presentations for project team meetings and governance reviews.
• Support preparation of toxicology content for regulatory submissions, including Investigator’s Brochures, INDs, CTDs, annual reports, marketing applications, and responses to regulatory agencies.
• Assist with investigative studies that evaluate unexpected toxicological findings, mechanisms of toxicity, species differences, or other scientific questions. • Contribute scientific input during project team discussions related to study design, interpretation, and development strategy.
Operational Responsibilities
• Coordinate GLP and non-GLP toxicology studies conducted at external CROs.
• Manage study startup activities including requests for proposals, timelines, protocol development, test article logistics, and study scheduling.
• Monitor study milestones, budgets, deliverables, and action items to ensure projects remain on schedule.
• Coordinate shipment and tracking of study materials, formulations, biological samples, and related documentation.
• Serve as a communication hub among toxicology, pathology, bioanalysis, DMPK, quality, regulatory affairs, CMC, project management, finance, and external vendors.
• Maintain study tracking systems, electronic files, databases, and documentation to support inspection readiness.
• Participate in improving operational workflows, study management tools, templates, and best practices within the toxicology organization.
Qualifications
• Bachelor’s or Master’s degree in Toxicology, Pharmacology, Biology, Veterinary Science, Life Sciences, or a related scientific discipline.
• Eight or more years of experience supporting nonclinical toxicology within the pharmaceutical, biotechnology, or CRO environment.
• Demonstrated experience coordinating outsourced nonclinical toxicology studies.
• Working knowledge of Good Laboratory Practice (GLP) regulations and the nonclinical drug development process.
• Strong organizational and project management skills with the ability to manage multiple concurrent studies.
• Excellent written and verbal communication skills with experience collaborating across multidisciplinary teams.
• Proficiency with Microsoft Office applications; experience using project management platforms, scientific databases, electronic document management systems, or data visualization software is advantageous.
Preferred Qualifications
• Experience supporting multiple therapeutic areas or drug modalities.
• Familiarity with regulatory documentation and global health authority submissions.