col-wideJob Description:
Zoetis Veterinary Medicine Research and Development (VMRD) is looking for a skilled Toxicologist to join the Toxicology group in Global Pharmacokinetics, Dynamics, Metabolism & Safety (GPDMS) based in Kalamazoo, MI, or remotely in a challenging and dynamic position that provides technical leadership and expertise in Project toxicology. This position will require a highly motivated and independent toxicologist to provide expertise in multidisciplinary mammalian toxicology disciplines supporting the safety assessment for early-stage programs through regulatory approval and beyond for new animal drugs and marketed products.
The responsibilities include:
- Serve as the Toxicology Technical Lead and Subject Matter Expert in the project teams to define and implement the safety strategy for veterinary medicinal product development and regulatory filing to meet global standards for safety.
- Design toxicology programs, study execution, data interpretation, and reporting of the non-clinical safety studies to achieve toxicology packages compliant with international guidance supporting livestock and companion animal programs with emphasis on underwriting the human food safety and human user safety assessments.
- Prepare technical submissions for health authorities to Establish Point of Departures (PoD), Acceptable daily intake (ADI), Permitted Daily Exposure (PDE), and Maximum Residue Limits (MRL) for human food safety and standards and product labeling for User Safety.
- Able to propose and gain concurrence with toxicology strategies, interpret and communicate data to project teams, management, and regulators, and identify multi-disciplinary solutions to recommend a course of action guiding complex projects.
- Prepare regulatory dossiers, including integrated summaries and safety expert reports for global regulatory authorities (US FDA-CVM, UK VMD, EMA CVMP, JECFA, JMAFF, APVMA, etc.)
- Collaborate with In vitro and Investigative Toxicology, Pathology, PKPD, Residue, Microbial Safety, Target Animal Safety, and Chemistry disciplines to elucidate toxicology findings of concern for research and development programs.
- Address regulatory queries from national authorities on submissions through formal and informal meetings, documents, position papers, and other communications to resolve regulatory issues pertaining to drug safety.
- Externally influence guidance through VICH and Industry Associations, publish reviewed peer-reviewed publications, and present research at internal and external scientific events
- Affinity with human pharmaceutical and chemical regulation monitoring, tracking developments in chemical regulation that may impact Zoetis testing requirements, products, and/or manufacturing.
