Senior Project Toxicologist / Scientific Lead

Zoetis Veterinary Medicine Research and Development (VMRD) is seeking a highly accomplished Sr. 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 :

Desirable skills, experience, and attributes :

Full time

Regular

Colleague

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Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following : (1) our company website at www.Zoetis.com / careers site, or (2) via email to / from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and / or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.