Manager - Toxicology Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager – Toxicology Operations based in the United States.

This role sits at the intersection of science, operations, and drug development, supporting the execution of critical toxicology studies that directly inform preclinical safety and regulatory decision-making. You will lead the operational backbone of nonclinical toxicology programs, ensuring studies are designed, outsourced, monitored, and delivered with scientific rigor and compliance. Acting as a key partner to toxicologists, CROs, and cross-functional stakeholders, you will help translate complex experimental work into actionable insights that shape global development programs. The environment is highly collaborative, science-driven, and fast-paced, with strong exposure to global project teams and regulatory processes. This position is ideal for someone who thrives in operational leadership while staying close to the scientific detail and impact of drug discovery. You will play a visible role in ensuring study quality, efficiency, and readiness across a portfolio of development programs.

Lead end-to-end operational execution of nonclinical toxicology studies, ensuring alignment with scientific, regulatory, and program objectives.

• Oversee study outsourcing activities including RFP processes, CRO selection, contracting, protocol development, monitoring, and final reporting.
• Serve as lead study monitor and sponsor representative for GLP and non-GLP toxicology studies conducted at external partners.
• Collaborate with toxicologists and scientific leads to contribute to study design, protocol refinement, and interpretation of experimental results.
• Evaluate toxicology data and provide structured summaries to support decision-making across program and leadership teams.
• Support the development and refinement of departmental SOPs, operational practices, and study execution standards.
• Track and analyze study execution metrics to improve efficiency, quality, and consistency across programs.
• Contribute to regulatory readiness activities, including inspection preparation and documentation review.
• Present study outcomes and insights to cross-functional teams, including global project and preclinical stakeholders.

Requirements:

Bachelor’s or Master’s degree in biological sciences or a related field, with 7+ years of experience in pharmaceutical or drug development environments.

• Strong background in toxicology study design, monitoring, interpretation, and regulatory nonclinical safety frameworks.
• Experience managing CRO-based studies, including outsourcing, contracting, and external scientific oversight.
• Ability to interpret complex scientific data and communicate findings clearly to technical and non-technical audiences.
• Demonstrated experience collaborating with cross-functional teams including toxicologists, regulatory, and program leadership.
• Strong troubleshooting skills with the ability to resolve operational or scientific issues during study execution.
• Excellent organizational and project management skills, with the ability to manage multiple concurrent studies.
• Strong written and verbal communication skills, including experience presenting scientific results to senior stakeholders.
• High attention to detail, with a strong understanding of compliance and quality standards in regulated environments.

Benefits:

• Competitive annual salary aligned with experience and expertise ($114,800 – $187,400 USD range referenced)
• Comprehensive health coverage including medical, dental, vision, life, and disability insurance
• Annual bonus opportunities and potential long-term incentive programs (including equity in some cases)
• Retirement savings plans (e.g., 401(k) and other country-specific options)
• Paid time off and family leave programs
• Wellness and employee support programs focused on physical and mental well-being
• Access to professional development and learning opportunities in a science-driven environment
• Exposure to global drug development programs with high-impact therapeutic outcomes
• Flexible benefits depending on role and location, including additional health and wellness resources