Zoetis - Kalamazoo, MI
posted about 2 months ago
The role involves designing and executing clinical development studies for companion animal pharmaceuticals and biopharmaceuticals, ensuring compliance with US CVM/CVB regulatory requirements. The successful candidate will be responsible for delivering both pilot and pivotal clinical studies that lead to product registrations. This position requires expertise in companion animal medicine and study conduct, contributing to various research and development projects in the companion animal pharmaceutical and biopharmaceutical sectors. Key responsibilities include overseeing the overall conduct of clinical studies in support of Veterinary Medicine Research & Development (VMRD) projects. This encompasses budgeting, investigator and site selection, protocol development and writing, monitoring, data analysis and interpretation, as well as report and technical section writing for regulatory dossiers. The candidate must ensure that all studies are conducted in accordance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory guidelines such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). Collaboration is a significant aspect of this role, as the candidate will work closely with Clinical and Project teams to define and track the progress of study status, activities, timelines, and outcomes. The ability to identify resource, time, and budget constraints is crucial, and the candidate will need to work with the Project Manager and Project Team Leader to devise solutions. Additionally, the role involves collaboration with Regulatory Affairs to secure protocol approval and support the submission of reports and data to the Center for Veterinary Medicine (CVM) or the Center for Veterinary Biologics (CVB) at the USDA, and may also extend to studies supporting approvals in the EU or other global regions.