Bayer Animal Health Manager of Pre-Clinical Development
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.Bayer Animal Health Manager of Pre-Clinical DevelopmentYOUR TASKS AND RESPONSIBILITIESThe primary responsibilities of this role, Bayer Animal Health Manager of Pre-Clinical Development are to: Formulate comprehensive pre-clinical (target animal safety, toxicology and pharmacokinetic) development plans for new products in development;Work collaboratively with the Director of Clinical Development North America as well as within and across project teams to adhere to time schedules and meet critical deadlines;Design and write protocols for toxicology, pharmacokinetic and target animal safety studies to gain information that will lead to regulatory approval of product. Select suitable research facilities and qualified study personnel;Initiate and monitor studies according to current federal regulations and company policies;Analyze and interpret results and author study reports;Prepare data for submission to regulatory agencies and present data to regulatory authorities and/or at scientific meetings;Coordinate and manage the pre-clinical group by coaching and devoloping personnelwhileproviding an environment for personnel development;Propose solutions or studies, including classic and innovative approaches, to address US and/or international product issues;Participate in meetings with regulatory authorities to present and explain the position of Bayer Animal Health with respect to study requirements or concerns associated with the toxicology or safety of specific products;Establish partnership-based working relationships with scientific experts within regulatory authorities and facilitate the scientific and regulatory review process for Bayer Animal Health products;Ensure Quality Assurance/Regulatory compliance and participate and/or lead administrative and procedural activities such as development of new Standard Operating Procedures. WHO YOU AREYour 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:Required Qualifications: DVM or a Ph.D. in an animal health related field with 5 years or more years of experience in product development within or closely associated with the pharmaceutical industry;Abilityto organize and manage a variety of projects at any one time demonstrating strict attention to detail;Current knowledge of all pertinent federal regulations under which all products are evaluated is essential;Working knowledge of word processing and spreadsheet computer programs;Must be self-motivated and able to work and learn without direct supervision;Excellent communication skills. Preferred Qualifications: An advanced degree (MS or Ph.D.), in addition to a DVM, would be desirable and should be in some specialty area or related field such as parasitology, internal medicine, pharmacology, pharmacokinetics/ pharmacodynamics, etc;Five or more years of experience in product development within or closely associated with the animal health pharmaceutical product development.YOUR APPLICATIONBayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the “Passion to Innovate” and the “Power to Change”, we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.Bayer is an Equal Opportunity Employer/Disabled/VeteransBayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.Apply for this job.