Description
Senior Scientist, Clinical with Boehringer Ingelheim Animal Health USA, Inc. in Athens, GA (Telecommuting permitted: Work may be performed within normal commuting distance from this office 2-3 days per week)
Job Duties: Demonstrate expertise in a specific project-relevant area or technology. May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects. Keep abreast of relevant literature. Independently initiate and coordinate strategic scientific experiments with a predefined goal including developing new methodologies, protocols and/or test procedures that contribute to innovation and core group/research goals and reflect expert knowledge. Responsible for the design, organization, conduct, timely completion and reporting of assigned clinical veterinary research and development studies to earn label claims and new product licenses/marketing authorizations consistent with the Target Product Profile, and to develop new claims and uses for existing products. Take on Study Director, Monitor and Investigator roles as necessary. Ensure compliance in the area of Good Laboratory Practice, Good Clinical Practice, Pharmacovigilance, animal welfare, and local and global regulatory requirements. Develop visibility outside of functional area and effectively interact scientifically with Key Opinion Leaders in relevant fields of research. Publish research in peer reviewed journals and present data at national/international meetings as requested. Skillfully collaborate across functions to assure clinical plans and activities for project teams are delivered efficiently, while supporting continuous improvement in quality including speed and value of processes supporting studies including protocol and forms, test article availability and suitability, monitoring effectiveness, statistical analysis, study event tracking, compliance, and excellent reporting. Develop and leverage external providers, academia and Contract Research Organizations as necessary. Mentor, coach and train colleagues, especially research associates/monitors/biologists, on best practices for study execution with flawless speed and compliance, professional and collaborative team member behaviors, accountability, and alignment within Clinical and with all stakeholders. Responsible for progress of clinical studies, including timelines, deliverable and budgetary responsibilities. Ensure that risks and changes to the Target Product Profile are communicated into the project team. Provide clinical input to the Target Product Profile and influence the Project from the clinical veterinary and scientific perspective. *Telecommuting permitted: Work may be performed within normal commuting distance from the Boehringer Ingelheim Animal Health USA, Inc. office in Athens, GA 2-3 days per week.
Work Schedule: 40 hours per week (8:00am to 5:00pm)
Description (Cont'd)
Job Requirements: Doctorate degree (U.S. or foreign equivalent) in Veterinary-related field and five (5) years of experience in the job offered or in a related role OR Master's degree (U.S. or foreign equivalent) in Veterinary-related field and eight (8) years of experience in the job offered or in a related role. Must have five (5) years of experience with: applying understanding of data and scientific decision processes and interpreting and reporting these data in well-supported conclusions targeted at achieving project objectives; conducting hands-on clinical studies and either laboratory or field studies, including GxP and non-GxP environments; and, leading projects, including project management and effectively working in an international and cross-functional matrix environment. Must have three (3) years of experience with: veterinary research and development, including research methodology, planning and organizing projects with a quality orientation, and striving for innovation and business process excellence; planning, conducting, reporting, analyzing and interpreting clinical studies; applying understanding of claim structure of veterinary vaccine products, including understanding of the veterinary business environment and how clinical study design impacts label language and commercial value of a product; applying understanding of the vaccine life cycle management process; applying understanding of global pharmaceutical regulatory requirements, such as FDA, USDA or EMA, and compliance; analyzing literature and technology trends in the veterinary and pharmaceutical industries; applying understanding of statistical principles in clinical studies; communicating effectively both orally and in writing in an inter-disciplinary and international environment; clinical veterinary practice in poultry; and, applying understanding of clinical risk assessment and risk mitigation principles. Must have successfully implemented or investigated scientific technologies as demonstrated by professional experience or scientific journal publication.
