Senior Manager, Clinical Development of Veterinary Medicine

Nature and Scope

The Senior Manager, Clinical Development of Veterinary Medicine provides strategic planning, implementation and management of veterinary pre-clinical and clinical studies (including GCP studies) to support regulatory approval of new animal health products. The incumbent will 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

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

• Provide overall leadership and clinical or veterinary technical expertise to the project team.
• Preparation of technical documents for CVM/ FDA submissions.
• Design and execute assigned pre-clinical and clinical veterinary protocols with assurance of scientific soundness per regulatory and ethical guidance recommendations, including early discovery and GCP studies.
• 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.
• Represent veterinary medicine across American Regent functions.
• Collaborate with veterinary pharmacovigilance for project specific safety monitoring and preparatory materials for regulatory submissions.
• 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.
• 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 or PhD in biological sciences preferred.
• Minimum of 8 years' experience in preclinical and clinical development in Veterinary Medicine or Animal Health, required. Experience with GCP studies preferred
• Area of therapeutic expertise; experience as a project team leader with major responsibility for at least one NADA submission desired.
• Experience with FDA-CVM desired.
• 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.
• Up to 25% travel may be required.

Expected Salary Range:

$142,000-$158,000

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.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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