Project Toxicology

Zoetis•Kalamazoo, MI

About The Position

Zoetis Veterinary Medicine Research and Development (VMRD) is looking for a skilled Toxicologist to join the Toxicology group within Clinical Pharmacology and Safety Sciences in Kalamazoo, MI, in a challenging and dynamic position that provides technical expertise in Project Toxicology. This position will require a highly motivated and independent toxicologist to provide expertise in multidisciplinary mammalian toxicology disciplines supporting all phases of development from discovery through late-stage development, regulatory approval, and lifecycle management for both small and large molecule therapeutics.

Requirements

PhD (or equivalent) in toxicology or a closely related discipline (e.g. pharmacology, physiology, medicinal chemistry, pathology, etc.).
At least 3 years of experience as a Project toxicologist in nonclinical safety assessment in veterinary or human health, spanning both small molecules and biologics/large molecules.
Master’s (MS) degree in toxicology or the above-mentioned disciplines with 8-10 years of experience will be considered.
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).
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.
Working knowledge of global regulatory requirements and expectations (e.g., ICH or VICH, FDA, EMA, etc.), with direct experience preparing submissions and engaging with health authorities.
Highly organized with strong problem-solving skills, able to prioritize effectively, make informed decisions, and collaborate in a matrix environment.
Strong interpersonal skills, with the ability to build lasting relationships and influence without direct authority and provide scientific leadership in project teams and cross-functional settings.
Excellence in technical writing and scientific communication (regulatory documents, protocols, reports, journal articles, dossiers, etc.).

Nice To Haves

Experience conducting human food safety and human user safety risk assessments.
Direct experience in the industry or CRO, particularly in conducting and reporting GLP repeat-dose (including chronic) toxicology studies.
Board certification in toxicology (DABT, ERT) is preferred.
Experience applying innovative approaches (e.g., NAMs, next-generation risk assessment tools, 3Rs strategies, waiver approaches) in toxicology assessments.

Responsibilities

Serve as the Toxicology Technical Lead and Subject Matter Expert on project teams to define and implement toxicology strategy for veterinary medicinal product development and regulatory submissions meeting global standards.
Apply cross-program toxicology and risk assessment expertise to anticipate safety challenges and provide project-level risk-based safety assessments.
Independently design, oversee, and interpret toxicology studies, integrating data into comprehensive safety packages.
Ensure compliance with international guidelines, with emphasis on human food safety and user safety assessments.
Propose and gain alignment on toxicology strategies, interpret and communicate data to project teams, management, and regulators, and identify multidisciplinary solutions to guide complex projects.
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 the 3Rs principles to advance ethical, efficient, and innovative toxicology strategies.
Prepare and defend technical dossiers to global health authorities, including establishing key safety thresholds (e.g., PoD, ADI, PDE, MRL, TTC) for human food safety, standards, and product labeling for user safety.
Lead interactions with regulators and address complex safety questions through formal and informal meetings, written responses, and position papers.
Collaborate 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.
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.