(Archived) Senior Manager, Clinical Development of Veterinary Medicine- Remote, TX

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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.