Director of Safety & Efficacy

The incumbent will be in charge of developing, coordinating and executing preclinical and clinical development programs of new product entities or extension of existing products from their inception through FDA, EPA or USDA approval.

The Director provides the Preclinical & Clinical Development staff with guidance, resources and materials to accomplish their objectives. The Director will assure the formulation of comprehensive preclinical and clinical development plans. This includes the guidance and oversight of the design of protocols for laboratory and field efficacy studies, the selection of suitable research facilities, contract research organizations and qualified researchers to execute protocols, and the preparation of data and reports for submission to regulatory agencies in order to gain approval of the products.

 Assures technical support to the Marketing, Veterinary Technical Services and Sales Departments before and after product launch. Provides the department with coaching, training and career development to maximize the potential of each individual and stimulate innovation in the workplace.

Represents Preclinical and Clinical Development in meetings with the FDA, EPA and USDA in order to negotiate and obtain agreements on behalf of the company. Provides guidance and oversees the cooperation with all departments in the US and in global headquarters during product development to assure that all parties involved adhere to time schedules and critical deadlines. Provides resources to investigate and evaluate new technologies, potential products and proposed product concepts

Qualifications include: Ph.D, DVM or MS and 10 years direct experience in medical research, clinical development or associated fields in the veterinary pharmaceutical industry. The individual must have expert knowledge of appropriate regulations especially as they apply to clinical disciplines. It is desirable that the individual have an in-depth knowledge of medical procedure, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials. Prior staff management of several personnel is required. The incumbent should demonstrate teambuilding. The incumbent should have a thorough knowledge of the pharmaceutical industry and government regulations with extensive experience in dealing with consultants and clinical investigators. Sound leadership skills and demonstrated ability to guide projects to successful conclusions must be evident. Ability to influence, to build relationships with regulatory bodies, and to successful conclusions must be evident. Ability to influence, to build relationships with regulatory bodies, and to successfully negotiate must have been demonstrated. The ability to work within a global team framework and a multi-cultural environment is required.

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