Senior Principal Scientist - Global Biologics, Swine
Zoetis Inc.
Manager Or Senior Manager, Swine Clinician
Zoetis Veterinary Medicine Research and Development (VMRD), Swine Biologicals group in Kalamazoo, MI is seeking a Manager or Senior Manager, Swine Clinician, to further efforts in vaccine discovery and development to support introduction of novel products to the global swine industry.
The successful candidate will design and execute swine biologics clinical studies in compliance with US CVB and/or EU EMA and/or other global regulatory requirements. The individual will have demonstrated skills and expertise in hypothesis-based research, clinical study design and conduct, and data interpretation. They will employ their skills and experience to deliver pilot and pivotal, clinical and non-clinical studies resulting in product registrations. This will include swine model development and refinement for demonstration of vaccine safety and efficacy testing. They will provide expertise in the areas of swine medicine, swine disease, critical study design, and study execution.
This job location is Kalamazoo, Michigan. Zoetis is the largest animal health company in the world with an industry-leading research and development team. The Swine Biologics group conducts basic and applied research to support development of safe and effective vaccines for the global swine industry. We are recruiting a highly motivated veterinary clinical scientist to contribute to advancing strategies in swine vaccine development at Zoetis. This scientist will have a specific focus on developing and conducting clinical studies in swine.
POSITION RESPONSIBILITIES:
- Responsible for overall design and conduct of clinical studies and programs in support of Veterinary Medicine Research & Development (VMRD) swine vaccine projects i.e. hypothesis driven study design, protocol development/writing, study monitoring including potential animal observations, data analysis and interpretation, report and technical section/regulatory dossier writing.
- Develop swine models of infectious disease in the appropriate age animals to support vaccine efficacy testing. Understand normal swine health and behavior to support vaccine safety testing.
- Ensure 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). Some GLP work may be required.
- Ability to proactively apply experience in a cross-functional team is required. 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 global regulatory agencies.
- Ability to organize and manage several projects and responsibilities at one time and prioritize work is required.
- Observations and applying hands-on expertise at laboratory and field study sites are required.
- Occasional travel is required.
- Prepare internal and external presentations and publications as appropriate to support team, organizational, and personal goals.
- Excellent written and verbal communication skills are required.
- Working knowledge of MS Office programs (Outlook, Word, Excel, PowerPoint) is essential.
- Support development of colleagues within the Clinical and Project teams.
EDUCATION AND EXPERIENCE:
- Minimum Experience: DVM/VMD or equivalent with experience in swine health.
- Preferred Experience: DVM/VMD or equivalent with 3 years' experience as a swine practitioner, in swine production, and/or PhD or MS in a swine health or production animal discipline, and/or experience in swine clinical development in the Animal Health Industry. Demonstrated leadership and mentoring skills.
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