Your tasks and responsibilities
The primary responsibilities of this role, Bayer Animal Health Director of Clinical Development of North America are to:
- Direct 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;
- Provide 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;
- Assure the formulation of comprehensive preclinical and clinical development plans for each new proposed product or line extension of existing products which 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;
- Provide 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;
- Represent Preclinical & Clinical Development in meetings with the FDA, EPA, and USDA in order to negotiate and obtain agreements on behalf of the company;
- Assure technical support to the Marketing, Veterinary Services, and Sales Departments before and after product launch;
- Provide 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;
- Provide 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;
- Promote 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;
- Work with the VP R&D in the development of Preclinical & Clinical Development budgets and project schedules;
- Approve department expenditures and ensures all administrative commitments are met.
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Ph.D., DVM, or MS and, 10 years direct experience in medical research, clinical development, or associated fields in the veterinary pharmaceutical industry;
- Must have extensive knowledge of appropriate regulations especially as they apply to clinical discipline;
- Prior staff management of several personnel and should demonstrate team building;
- 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, build relationships with regulatory bodies, successfully negotiate, and work within a global team framework and a multi-cultural environment.
- An in-depth knowledge of medical procedure, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trial.