Manager - Toxicology Operations - Remote

📋 Description

• • Lead scientific, technical, and operational tasks to support toxicology program representatives and department leadership in a remote capacity.
• • Independently manage the contracting, drug supply, protocol development, and conduct of both non-GLP and GLP toxicology studies through remote and on-site CRO monitoring.
• • Serve as the lead study monitor or sponsor representative with administrative oversight for toxicology studies conducted at CROs.
• • Collaborate with lead scientists to provide direct input and suggestions on study designs and protocols for nonclinical safety studies.
• • Coordinate end-to-end study outsourcing activities including RFP issuance, contracting, protocol development, monitoring, and final reporting.
• • Evaluate experimental data from toxicology studies and align with program toxicologists to interpret, summarize, and present results for internal decision-making.
• • Contribute to the development and definition of standard departmental practices, including SOPs, for the conduct and reporting of toxicology studies.
• • Collect and evaluate metrics related to the performance and efficiency of toxicology studies to drive continuous improvement.
• • Present toxicology study results to preclinical subteams and global project teams as required, ensuring clear communication of findings.
• • Assist in regulatory inspection readiness activities by ensuring study documentation and processes meet compliance standards.
• • Travel domestically and internationally on an occasional basis to support CRO site visits and study-related activities.
• • Operate with autonomy while ensuring alignment with departmental and organizational goals in a fast-growing, science-driven environment.
• • Maintain expertise in regulated nonclinical safety study design, monitoring, and interpretation within a pharmaceutical drug development context.
• • Troubleshoot operational and scientific challenges that arise during the conduct of toxicology studies to maintain study timelines and data integrity.
• • Support cross-functional teams by providing toxicology insights that inform broader preclinical and clinical development strategies.
• • Ensure all toxicology study activities comply with regulatory expectations and internal quality standards.
• • Contribute to a culture of scientific rigor, collaboration, and patient-centric innovation in support of life-changing medicine development.