Responsible for the safety and efficacy in the target species for new animal pharmaceutical research and development projects, line extensions and maintaining existing licensed products. Provides clinical study design and implementation including resource and budget planning from protocol to execution and to final study report for submission to regulatory agencies for animal pharmaceutical projects in both lab and field conditions. Fulfills a role as a subject matter expert in representing his/her function (e.g. on development teams, regulatory authority meetings and key Opinion Leaders). Acts as the Clinical Representative as assigned for all stages of product development. Presents clinical content to regulatory authorities as required and ensures compliance with all applicable regulatory and animal welfare principles. The incumbent may lead a Clinical Team as Clinical Leader and is responsible for development and implementation of the clinical strategy. The Clinical Leader serves as the representative on the Core Team.
DVM from an accredited institution, plus five (+5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization.
In lieu of DVM, will accept PhD or Masters from an accredited institution (with significant experience in a veterinary-relevant field such as laboratory animal medicine) plus five (+5) years of experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization.
Considerable experience (> 3 years) in veterinary research & development is preferable.
Hands-on experience with clinical and laboratory/field studies (GxP and non GxP)
Solid / basic understanding of claim structure of veterinary pharmaceutical products including sound knowledge of the veterinary business environment and how clinical design impacts label language and commercial value of a product.
Able to effectively work in an international and cross-functional matrix environment
Knowledge of global regulatory requirements (e.g. FDA, EMA) and compliance.
Experience in analyzing literature and technology trends in the veterinary and pharmaceutical industry
Experience with planning, conducting, reporting, analyzing and interpreting clinical studies
Basic understanding of statistical principles in clinical studies is a plus.
Understands principles of clinical risk assessment and risk mitigation
An analytical thinker.
Excellent skills in understanding data and scientific decision processes, and in interpreting and reporting these data in well supported conclusions targeted at achieving project objectives.
Strong leadership skills.
Able to lead (e.g. the Clinical team) without formal authority.
Research methodology experience.
A problem solver.
Outstanding / Good communication and interpersonal skills.
A collaborative team player.
Values diversity and inclusion.
Possesses a customer service orientation, delivering results and executing in a fast and focused manner.
Exceptional planning and organizational skills with a quality orientation.
Strives for business process excellence.
Accepts accountability and ownership.
Exhibits integrity and trust.
Willingness to travel.
Clinical veterinary practice experience is preferred.
English: Fluent (read, write and speak)
Board Certification and/or advanced degree (MS or PhD) in addition to DVM is a plus.
A minimum of five (5) years of broad experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization or equivalent combination of education and experience.
Demonstrates industry-leading knowledge of field.
Ability to communicate effectively both orally and in writing in an inter-disciplinary and international environment.
Leadership experience: one to three (1-3) years leading projects is a plus.
Demonstrated knowledge of the Pharmaceutical life cycle process.
Experienced in project/program management.
Exhibits business and technical knowledge.
Internal Number: Senior Scientist, Clinica
About Boehringer Ingelheim
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.