Scientific Lead, Project Toxicology

Role Description

Scientific Lead, Project Toxicology

Zoetis Veterinary Medicine Research and Development (VMRD) is seeking a highly accomplished Project toxicologist to join the Toxicology group within Clinical Pharmacology and Safety Sciences in Kalamazoo, MI. This senior scientific role provides technical strategy, regulatory expertise, and project toxicology leadership in toxicology, ensuring the human food safety and user safety of our innovative veterinary medicines and established products.

The responsibilities include:

• Scientific Leadership: Serve as a senior subject matter expert and individual contributor, representing Toxicology on cross-functional project teams. Lead program-level toxicology strategy for product development, ensuring scientific approaches and safety assessments are aligned with global standards from discovery through post-approval.
• Portfolio Impact: Apply cross-program toxicology and risk assessment expertise to anticipate safety challenges and provide project-level safety risk–based assessments. Contribute toxicology input that supports portfolio decision-making across therapeutic areas and development stages, with safety risks clearly articulated and considered in governance reviews, risk/benefit assessments, and senior leadership discussions on program prioritization.
• Regulatory Submissions and Engagement: Prepare and defend technical dossiers and submissions to global health authorities, including establishing key safety thresholds (e.g., PoD, ADI, PDE, MRL, TTC, etc.). Lead interactions with regulators and address complex safety questions through meetings, written responses, and position papers.
• Nonclinical Safety Assessment: Independently design, oversee, and interpret toxicology programs, integrating data into comprehensive safety packages. Ensure compliance with international guidance, with emphasis on human food safety and user safety assessments.
• Mutagenic Impurities Assessment: Lead the evaluation of mutagenic and genotoxic impurities in accordance with global regulatory guidance (e.g., ICH M7, VICH). Design and interpret studies, assess risk, and provide regulatory justifications to ensure compliance and product safety.
• Innovative Approaches & 3Rs: Champion the use of New Approach Methodologies (NAMs), next-generation risk assessment tools, and weight-of-evidence frameworks. Apply waiver approaches where scientifically justified and promote 3Rs principles to advance ethical, efficient, and innovative toxicology strategies.
• Cross-Disciplinary Collaboration: Partner with Discovery and Computational Toxicology, Pathology, PKPD, Human Food Safety Residue, Microbial Safety, Target Animal Safety, Occupational Toxicology, Chemistry, Environmental Safety, Global Regulatory Affairs, and other disciplines to elucidate toxicology findings of concern for research and development programs.
• External Influence: Represent Zoetis in scientific forums and industry consortia, including VICH and industry associations. Contribute to the development of regulatory guidance, publish peer-reviewed research, and present findings at both internal and external scientific meetings.
• Regulatory Intelligence: Monitor evolving trends in human and veterinary pharmaceutical and chemical regulation, proactively assessing implications for Zoetis’ products, testing requirements, and manufacturing.

Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed.

Minimum Skills: 

• PhD (or equivalent) in toxicology or a closely related discipline (e.g., pathology, pharmacology, physiology, medicinal chemistry).
• At least 10 years of experience as a Project toxicologist in nonclinical safety assessment in veterinary or human health, spanning both small molecules and biologics/large molecules.
• Experience in developing regulatory strategy for drug development, including innovative study designs, and the ability to interpret, integrate, and apply toxicology data for veterinary and human safety assessment.
• Advanced expertise in safety risk assessment and interpretation of toxicological findings from in vivo, in vitro, in silico, and non-animal methodologies, applying weight-of-evidence approaches to support regulatory decision-making.
• Demonstrated expertise across multiple toxicology work streams, such as systemic in vivo toxicity in rodents and non-rodents (general toxicology and specialty areas including neurotoxicity, immunotoxicology, and cardiovascular safety).
• Working knowledge of global regulatory requirements and expectations (e.g., VICH, FDA, EMA, USDA etc.), with direct experience preparing submissions and engaging with health authorities.