Designs and executes companion animal pharmaceutical and biopharmaceutical Clinical Development studies in compliance with US CVM/CVB regulatory requirements. Deliver pilot and pivotal, clinical studies resulting in product registrations. Provides expertise in the areas of companion animal medicine and study conduct to companion animal pharmaceutical and biopharmaceutical research and development phase projects.
POSITION RESPONSIBILITIES
Is responsible for overall conduct of clinical studies in support of Veterinary Medicine Research & Development (VMRD) companion animal research and development projects i.e. budgeting, investigator/site selection, protocol development/writing, monitoring, data analysis and interpretation, report and technical section/regulatory dossier writing.
Ensure that studies are conducted in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements and guidelines (e.g., Good Clinical Practice and Good Laboratory Practice).
Collaborate with both Clinical and Project teams to define and track progress of study status, activities, timelines, and outcomes. Identify when resource, time, and/or budget constraints occur and work with the Project Manager and Project Team Leader to identify solutions.
Collaborate with Regulatory Affairs to gain protocol approval and subsequently support the submission of reports/data to either the Center for Veterinary Medicine (CVM) or Center for Veterinary Biologics (CVB), USDA. May also be involved in studies to support approvals in the EU or the rest of the world.
EDUCATION AND EXPERIENCE
Minimum Experience:
DVM with 3 year's experience in U.S. companion animal private practice
Preferred Experience:
PhD, and/or Board Certification in a companion animal discipline, and/or experience in companion animal clinical development in the Animal Health Industry
Full time
Regular
Colleague
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