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Senior Manager, Clinical Development of Veterinary Medicine- Remote, TX

American Regent, Inc.

Last Updated: 5/03/22

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Job Description

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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.
  • 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).
  • Minimum of 8 years’ experience in preclinical and clinical development in Veterinary Medicine or Animal Health.
  • Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, and Medical Affairs.
  • 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.

Preferred Skills

  • 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.
  • Prior management experience as evidence by previous direct reports desired.
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Company Details

Shirley, New York, United States
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.