New Product Development Manager

This role contributes to New Product Development by designing, coordinating, and executing both pilot and pivotal in-life studies (laboratory non-clinical and field clinical) in compliance with global regulatory standards and guidelines. Furthermore, this role will serve to support to post approval pharmacovigilance by providing pre-approval technical knowledge and understanding of commercialized products.

Primary Responsibilities/Activities:

Responsibilities include:

• Independently evaluate appropriate medical literature, create clinical assessment tools, identify and acquire applicable technology and design/implement relevant disease models to assess new therapeutic approaches.
• Coordinating Contract Research Organizations (CROs) to conduct studies as well as other study functions such as developing protocols/reports, monitoring, data management, and creation of technical content.
• Assist in the raw data review and audit of reports as well as regulatory submissions pursuant to FDA (A)NADA approval and other regulatory authorities.
• Development of project timelines and relevant milestones with corresponding budgetary needs for evaluation by leadership.
• Maintain collaborative reporting of milestone achievement to Portfolio Project Manager.
• Participate and lead (if appropriate) in multi-disciplinary teams and work in close collaboration with a range of scientists and nonscientist stakeholders across the organization.

Qualifications:

• Doctor of Veterinary Medicine (DVM)
• 8+ years institutional experience (veterinary practice, industry and/or academia) working with multidisciplinary, goal-directed scientific team, clinical practice (cat, dog, horse), veterinary medicine experience, research experience in conducting and reporting scientific animal studies using sound principles of statistical experimental design and outcomes of interpretation, scientific technical writing, data collection, organization, and analysis.
• Proficiency in knowledge of current veterinary therapeutics, mechanisms of pathophysiology and pharmacology (including pharmacokinetics).
• Working knowledge of computer applications for mathematical spreadsheets, document creation, presentation, database, communication and project management functions, introductory familiarity with GLP and GCP requirements
• Excellent professional verbal and written communication skills at the scientific and non-scientific level
• Positive contributor to team operations
• Good track record of problem solving
• Effective time management
• Self-starting motivated learning, commitment to continual process improvement.
• Travel up to 40%