Bayer Animal Health Director of Clinical Development for North America
Bayer Healthcare, Animal Health
Job Requirements-Ph.D., DVM, or MS and, 10 years direct experience in medical research, clinical development, or associated fields in the veterinary pharmaceutical industry is required;
-The individual must have expert knowledge of appropriate regulations especially as they apply to clinical discipline;
-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 trial;
-Prior staff management of several personnel is required. The incumbent should demonstrate teambuilding;
-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 successfully negotiate must have been demonstrated. The ability to work within a global team framework and a multi-cultural environment is required.
Job DescriptionThe primary responsibilities of this role, Bayer Animal Health Director of Clinical Development of North America are:
-Directs the Preclinical & Clinical Development staff in the planning, preparation, coordination, and execution of preclinical and clinical development programs. Assures that staff structure and activities are organized, innovative, creative, and flexible to accommodate the many challenges that occur during the years of product development. Provides the department staff with coaching, training and career development opportunities to maximize the potential of each individual, build teamwork and problem solving skills and stimulate innovation in the workplace;
-Assures the formulation of comprehensive preclinical and clinical development plans for each new proposed product or line extension of existing products. 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;
-Provides guidance and oversees the cooperation with all departments in the US and in global headquarters (Project Management, Formulations, Analytical Chemistry, Toxicology, Regulatory Affairs, Quality Assurance, Marketing, Technical Services, and Production) during product development to assure that all parties involved adhere to time schedules and meet critical deadlines;
-Represents Preclinical & Clinical Development in meetings with the FDA, EPA, and USDA in order to negotiate and obtain agreements on behalf of the company.
-Assures technical support to the Marketing, Veterinary Services and Sales Departments before and after product launch;
-Provides resources to investigate and evaluate new technologies, potential products, and proposed product concepts presented by Global R&D or Business Development on as needed basis;
-Provides guidance and oversees participation in departmental and inter-departmental activities such as QA/regulatory and corporate compliance, revisions or creation of new Standard Operating Procedures, Performance Management Process, etc.
-Promotes the interests of Bayer Animal Health and the Animal Health Industry and influences improvements in FDA, EPA, and USDA regulatory processes by participation in Animal Health Institute Working Groups and Leadership Committee;
-Works with the VP R&D in the development of Preclinical & Clinical Development budgets and project schedules. Approves department expenditures and ensures all administrative commitments are met.
$100,000 or more
Minimum Years Experience:
11 to 15
0 to 25%
# of Openings:
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