Nature and Scope
Provide strategic planning, implementation and management of veterinary pre-clinical and clinical studies to support animal health product development. Serve as a scientific and clinical resource to cross-functional teams involved in veterinary product initiatives inclusive of business development opportunities.
Essential Duties and Responsibilities
- Design and execute assigned pre-clinical veterinary protocols with assurance of scientific soundness per regulatory and ethical guidance recommendations.
- Design and execute assigned clinical veterinary protocols with assurance of scientific soundness per regulatory and ethical guidance recommendations.
- Protocol and therapeutic area training of project teams for the conduct of pre-clinical and clinical studies, inclusive of vendor management as appropriate.
- Assistance in investigator identification for preclinical and clinical veterinary studies.
- Monitor pre-clinical and clinical studies and projects, inclusive of consultants, study site investigators, academic research organizations, and clinical research organizations.
- Participation in and/or presentation at Investigator Meetings and other educational venues.
- Participation in after-hours medical coverage for clinical projects if required.
- Collaborate with veterinary pharmacovigilance for project specific safety monitoring and preparatory materials for regulatory submissions.
- Veterinary medical, scientific, and technical support for project management, data management, biometrics, and medical writing.
- Pre-Clinical and Clinical Veterinary study report writing and/or critical medical review and assessment of written documents.
- Assist in competitor identification and analysis, if assigned.
- Participation in Veterinary Medicine educational programs.
- Training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) expertise.
Education Requirements and Qualifications
- Veterinary degree (DVM) required.
- Minimum of 8 years’ experience in preclinical and clinical development in Veterinary Medicine or Animal Health, required.
- Area of therapeutic expertise; experience as a project team leader with major responsibility for at least one NADA submission desired.
- Experience as direct liaison with FDA-CVM. AH regulatory experience desired.
- Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, and Medical Affairs.
- Prior management experience as evidence by previous direct reports desired.