Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• 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.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.
• Ability to prioritize and perform multiple tasks simultaneously.
• Ability to make decisions independently and with appropriate input.
• Flexibility in adapting to multiple therapeutic areas interchangeably.
• Excellent oral and written English communication skills.

Expected Salary Range:

$140,000 - $160,000

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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