Scientific Lead, Project Toxicology at Zoetis

Kalamazoo, Michigan, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Veterinary Medicine, PharmaceuticalsIndustries

Requirements

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

Responsibilities

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 alignment with global standards from discovery through post-approval
Apply cross-program toxicology and risk assessment expertise to anticipate safety challenges, provide project-level safety risk-based assessments, and contribute toxicology input to support portfolio decision-making across therapeutic areas and development stages, with safety risks articulated in governance reviews, risk/benefit assessments, and senior leadership discussions
Prepare and defend technical dossiers and submissions to global health authorities, including establishing key safety thresholds (e.g., PoD, ADI, PDE, MRL, TTC); lead interactions with regulators and address complex safety questions through meetings, written responses, and position papers
Independently design, oversee, and interpret toxicology programs, integrating data into comprehensive safety packages; ensure compliance with international guidance, emphasizing human food safety and user safety assessments
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
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
Partner with cross-disciplinary teams including Discovery and Computational Toxicology, Pathology, PKPD, Human Food Safety Residue, Microbial Safety, Target Animal Safety, Occupational Toxicology, Chemistry, Environmental Safety, and Global Regulatory Affairs to elucidate toxicology findings of concern
Represent Zoetis in scientific forums and industry consortia (e.g., VICH), contribute to regulatory guidance development, publish peer-reviewed research, and present findings at internal and external meetings
Monitor evolving trends in human and veterinary pharmaceutical and chemical regulation, proactively assessing implications for Zoetis’ products, testing requirements, and manufacturing
Travel up to 10% for collaborations, regulatory engagements, or conferences as needed