Zoetis is currently seeking a Companion Animal Clinical Development Clinician to join our team in Kalamazoo, MI. In this role, you will design and execute companion animal pharmaceutical and biopharmaceutical clinical development studies in compliance with U.S. CVM/CVB regulatory requirements. You will deliver pilot and pivotal clinical studies that support product registrations and provide expertise in companion animal medicine and study conduct to research and development phase projects.
RESPONSIBILITIES
Lead the overall conduct of clinical studies in support of 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 Standard Operating Procedures (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, and/or budget constraints and work with the Project Manager and Project Team Leader to develop appropriate solutions.
Partner with Regulatory Affairs to obtain protocol approval and support submission of reports and data to the Center for Veterinary Medicine (CVM) and/or the Center for Veterinary Biologics (CVB), USDA. May also contribute to studies supporting regulatory approvals in the EU and other international markets.
EDUCATION AND EXPERIENCE
Minimum Qualifications
Doctor of Veterinary Medicine (DVM)
Minimum of 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. regulatory requirements for animal health products, including Center for Veterinary Medicine (CVM) and Center for Veterinary Biologics (CVB) guidelines
Experience in companion animal clinical development within the Animal Health industry 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 requirements
Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
Demonstrated 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
Full time
Regular
Colleague
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Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [email protected] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
