Nature and Scope The Medical Director, Head of Veterinarian Affairs, Drug Development, Affairs, and Sciences (DDAS) is responsible for the strategy, tactical planning, and execution of clinical trials, medical affairs activities, and pharmacovigilance activities related to veterinary products. The role will report directly to the Vice President, Chief Medical Officer and work collaboratively with the Marketing and Sales teams of the Animal Health Division.
Essential Duties and Responsibilities • Extrapolation from research in animal models and comparative biology to potential clinical trials aligned with regulatory strategies for the approval of new drugs in animals. • Design and lead the execution and analysis of equine and canine clinical trials. • Investigate and validate disease targets and therapeutic interventions for equine and canine product development. • Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. • Vendor management of clinical monitors and coordinators trained to conduct GCP qualified studies. • Vendor management of clinical trials, field studies, targeted disease research, and product development. • Network with universities and colleges with veterinary medicine programs. • Manage veterinary scientists and team in assignments for drug development, medical affairs, pharmacovigilance, and safety surveillance. • Assure alignment with leadership and cross-functional teams. • Lead, assign responsibility, and assure deliverables for direct reports and the team. • Fiscal responsibility for the Veterinary, DDAS cost center. • Perform any other tasks/duties as assigned by management.
Qualifications and Requirements • Veterinary Medicine Degree, with Board Certification in small or large animal internist program required. • Ten or more years of experience in the pharmaceutical industry with strong evidence of leadership and management skills. • Working knowledge of FDA Center for Veterinary Medicine (CVM) regulations as they pertain to the company’s drug products. • Ability to make decisions independently and with appropriate input. • Ability to work in a cross-matrix environment and handle multiple priorities simultaneously. • Excellent oral and written communication skills. • Ability to travel 20%-25% of the time to attend off-site meetings, conferences, and business opportunity assessments.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Internal Number: 2449
About American Regent, Inc.
American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectable pharmaceutical drugs for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.