Director – Product Development R&D

Our client’s Research and Development group is responsible for the ongoing support of existing products as well as the development of new products in a regulated environment. The Director of the Product Development group will lead a group of Development Managers, responsible for planning and executing research plans resulting in registrations of new animal health pharmaceuticals. The Director will be responsible for ensuring that all R&D projects have effective, comprehensive project planning and project management and coordination of resources between Regulatory Affairs and Pharmaceutical Development groups. This Director must have well developed skills and expertise in Project Management. Keys to success for this Manager are having a technical background, experience with CGP and GLP studies, experience with FDA and EPA regulatory authorities and a strong scientific perspective.

Required qualifications include:  Advanced degree: M.S., Ph.D, or D.V.M (or equivalent). Training and experience with broad-scope project management. Experience in research and regulatory affairs including interaction with governmental agencies. Understanding of product development, protocols, research reports and dossier preparation. Good written and verbal communication skills with ability to interact with all members of multi-discipline project teams. Comfortable working via cross-cultural and international teams. Functional knowledge and experience with Microsoft Project or other Project Management tools Training and knowledge of CFRs relevant to FDA/CVM and EpA. Training and knowledge of Good Clinical Practices (CGPs) and Good Laboratory Practices (GLPs). Travel 40-50% including domestic and international travel. Will have frequent contact with outside contractors, investigators and opinion leaders, and non-US development teams.

• Comfortable working via cross-cultural and international teams.
• Functional knowledge and experience with Microsoft Project or other Project Management tools.
• Training and knowledge of regulations regarding the use of animals in research.
• Working knowledge of CFRs relevant to FDA/CVM and EPA.
• Training and knowledge of Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs).

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