Clinician, Companion Animal Clinical Development
Zoetis
12 hours ago
Remote friendly (Kalamazoo, MI)
United States
Clinical Research and Development
Companion Animal Clinical Development Clinician (Kalamazoo, MI)
Design and execute companion animal pharmaceutical and biopharmaceutical clinical development studies in compliance with U.S. CVM/CVB regulatory requirements; deliver pilot and pivotal clinical studies supporting product registrations.
Responsibilities
- Lead the overall conduct of clinical studies for Veterinary Medicine Research & Development (VMRD) companion animal R&D projects, including:
- Budget development and management
- Investigator and site selection
- Protocol development and writing
- Study monitoring
- Data analysis and interpretation
- Report writing and preparation of technical sections for regulatory dossiers
- Ensure studies are conducted in compliance with applicable requirements, including SOPs, corporate policies, and regulatory guidelines (e.g., Good Clinical Practice and Good Laboratory Practice).
- Collaborate with Clinical and Project Teams to define and track study status, activities, timelines, and outcomes; identify resource/timeline/budget constraints and work with Project Manager/Team Leader on solutions.
- Partner with Regulatory Affairs to obtain protocol approval and support submission of reports and data to USDA Center for Veterinary Medicine (CVM) and/or Center for Veterinary Biologics (CVB); may contribute to EU and other international regulatory-approval studies.
Minimum Qualifications
- Doctor of Veterinary Medicine (DVM)
- 3+ years of experience in U.S. companion animal private practice
- Experience managing clinical cases involving therapeutics and/or biologics in companion animals
- Experience designing or contributing to clinical protocols or research studies
Preferred Qualifications
- PhD
- Board Certification in a companion animal discipline
- Working knowledge of U.S. animal health product regulatory requirements (CVM/CVB)
- Experience interacting with regulatory agencies (e.g., technical section authorship or direct communication with CVM/CVB)
- Prior authorship of regulatory dossiers supporting product approvals
- Experience with global regulatory submissions (EU, Canada, Australia, etc.)
- Familiarity with pharmacovigilance and post-marketing surveillance
- Experience with electronic data capture (EDC) systems and CTMS
- Leadership of cross-functional teams in a matrixed organization
- Experience managing CROs and external study sites
- Publication record in peer-reviewed veterinary journals
- Advanced training in clinical pharmacology, epidemiology, or translational medicine
Design and execute companion animal pharmaceutical and biopharmaceutical clinical development studies in compliance with U.S. CVM/CVB regulatory requirements; deliver pilot and pivotal clinical studies supporting product registrations.
Responsibilities
- Lead the overall conduct of clinical studies for Veterinary Medicine Research & Development (VMRD) companion animal R&D projects, including:
- Budget development and management
- Investigator and site selection
- Protocol development and writing
- Study monitoring
- Data analysis and interpretation
- Report writing and preparation of technical sections for regulatory dossiers
- Ensure studies are conducted in compliance with applicable requirements, including SOPs, corporate policies, and regulatory guidelines (e.g., Good Clinical Practice and Good Laboratory Practice).
- Collaborate with Clinical and Project Teams to define and track study status, activities, timelines, and outcomes; identify resource/timeline/budget constraints and work with Project Manager/Team Leader on solutions.
- Partner with Regulatory Affairs to obtain protocol approval and support submission of reports and data to USDA Center for Veterinary Medicine (CVM) and/or Center for Veterinary Biologics (CVB); may contribute to EU and other international regulatory-approval studies.
Minimum Qualifications
- Doctor of Veterinary Medicine (DVM)
- 3+ years of experience in U.S. companion animal private practice
- Experience managing clinical cases involving therapeutics and/or biologics in companion animals
- Experience designing or contributing to clinical protocols or research studies
Preferred Qualifications
- PhD
- Board Certification in a companion animal discipline
- Working knowledge of U.S. animal health product regulatory requirements (CVM/CVB)
- Experience interacting with regulatory agencies (e.g., technical section authorship or direct communication with CVM/CVB)
- Prior authorship of regulatory dossiers supporting product approvals
- Experience with global regulatory submissions (EU, Canada, Australia, etc.)
- Familiarity with pharmacovigilance and post-marketing surveillance
- Experience with electronic data capture (EDC) systems and CTMS
- Leadership of cross-functional teams in a matrixed organization
- Experience managing CROs and external study sites
- Publication record in peer-reviewed veterinary journals
- Advanced training in clinical pharmacology, epidemiology, or translational medicine