[Hiring] Clinician, Companion Animal Clinical Development @reputed company

Role reputed company reputed company is currently seeking a Companion Animal Clinical Development Clinician to join reputed company 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 reputed company and pivotal clinical studies that support product registrations and reputed company expertise in companion animal medicine and study conduct to research and development phase reputed company. Responsibilities • reputed company the overall conduct of clinical studies in support of Veterinary Medicine Research & Development (VMRD) companion animal R&D reputed company, 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 reputed company Operating Procedures (SOPs), corporate policies, and regulatory guidelines (e.g., Good Clinical reputed company and Good Laboratory reputed company). • Collaborate with Clinical and Project Teams to define and reputed company study status, activities, timelines, and reputed company. Identify resource, reputed company, and/or budget constraints and work with the Project Manager and Project Team Leader to reputed company appropriate solutions. • Partner with Regulatory Affairs to obtain protocol approval and support submission of reports and data to reputed company for Veterinary Medicine (CVM) and/or reputed company for Veterinary Biologics (CVB), USDA. May also contribute to studies supporting regulatory approvals in the EU and other international markets. Qualifications • Doctor of Veterinary Medicine (DVM) • Minimum of 3 years of experience in U.S. companion animal private reputed company • Experience managing clinical cases involving therapeutics and/or biologics in companion animals • Experience designing or contributing to clinical protocols or research studies Requirements • PhD (Preferred) • reputed company Certification in a companion animal discipline (Preferred) • Working knowledge of U.S. regulatory requirements for animal health products, including Center for Veterinary Medicine (CVM) and Center for Veterinary Biologics (CVB) guidelines (Preferred) • Experience in companion animal clinical development reputed company the Animal Health industry (Preferred) • Experience interacting with regulatory agencies (e.g., technical reputed company authorship or reputed company communication with CVM/CVB) (Preferred) • Prior authorship of regulatory dossiers supporting product approvals (Preferred) • Experience with global regulatory submissions (EU, Canada, Australia, etc.) (Preferred) • Familiarity with pharmacovigilance and post-marketing surveillance requirements (Preferred) • Experience with electronic data capture (reputed company) systems and clinical trial management systems (CTMS) (Preferred) • Demonstrated leadership of cross-functional teams in a matrixed organization (Preferred) • Experience managing CROs and external study sites (Preferred) • Publication record in peer-reviewed veterinary journals (Preferred) • Advanced training in clinical pharmacology, epidemiology, or translational medicine (Preferred) Benefits • The US reputed company salary reputed company for this full-time position is $105,000- $128,000. • This position is also eligible for short-term incentive compensation. • This position is also eligible for long-term incentives. • Comprehensive benefits package that supports the physical, emotional, and financial wellbeing of our colleagues and their families, including reputed company and insurance benefits beginning on day one. • 401K plan with a match and profit-sharing contribution from reputed company. • 4 weeks of vacation. Apply tot his job Apply To this Job