Education : EQUIVALENTEXPERIENCE
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better – join our team today
Your Role
As Principal Research Scientist, you will conduct and coordinate the development of global Pet Health clinical development programs (effectiveness and target animal safety (TAS)) from their inception through approval in initial target geographies. Reporting to the Clinical Leader, you will have the opportunity to design and execute studies that deliver Elanco's innovation pipeline to our customers.
Your Responsibilities
* Clinical Planning: Formulate comprehensive clinical development plans for new products and build effective relationships across R&D, Regulatory Affairs, Marketing, and Manufacturing to ensure critical deadlines and quality attributes (GCP, GLP) are met.
* Study Execution: Design and write protocols for laboratory and field efficacy studies and TAS in cooperation with Biostatistics and Regulatory Affairs.
* Site Management: Select suitable research facilities and qualified Contract Research Organizations (CROs) to execute protocols and ensure study monitoring aligns with global regulations and company policies.
* Data Analysis & Reporting: Analyze and interpret results with support from Data Management and Medical Writing to author comprehensive study reports.
* Regulatory Collaboration: Work with Regulatory Affairs to prepare data for submission and present findings to regulatory authorities and at scientific meetings.
* Compliance & Excellence: Ensure quality assurance and regulatory compliance while leading administrative activities to improve functional procedures.
* Scientific Leadership: Attend scientific meetings and stay abreast of advances in the animal health industry and veterinary profession.
What You Need to Succeed (Minimum Qualifications)
* Education: A DVM or a Ph.D. in an animal health-related field is preferred (an MS with significant experience will be considered).
* Experience: A minimum of 5 years of experience in product development within or closely associated with the pharmaceutical industry.
* Regulatory Knowledge: Current knowledge of pertinent global, national, and federal regulations for therapeutic product evaluation.
* Skills: Outstanding organizational skills with the ability to manage multiple projects simultaneously, strict attention to detail, and excellent communication skills.
* Mindset: Self-motivated with the ability to work and learn independently without direct supervision.
What Will Give You a Competitive Edge (Preferred Qualifications)
* Proven experience acting as a strategist and facilitator to drive clinical programs.
* Strong working knowledge of GCP/GLP/GMP and experience working directly with regulatory authorities.
* Demonstrated ability to manage and collaborate with external partners.
* Achievements in key competencies: Strategic Mindset, Business Insight, Cultivating Innovation, and Driving a Vision.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status