As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Global Clinical Development – Farm Animal Research Scientist is responsible for the strategy, design, and conduct of clinical efficacy and safety programs for global farm animal vaccine development projects. The role has the following core responsibilities:
- Ensure the collection of accurate and complete datasets of efficacy and safety studies in compliance with the required global regulatory standards and guidelines.
- Contribute as a clinical subject matter expert to and/or lead clinical project teams for the development and licensure of farm animal vaccines.
- Contribute as a clinical subject matter expert to and/or lead product line extension and/or product remediation projects.
This role necessitates developing and maintaining strong relationships with functional partners in manufacturing, regulatory affairs, quality, commercial and other areas of R&D.
Please Note: We will consider Teleworker/Remote for this position
Basic Minimum Qualifications:
- Familiar with GCP / GLP study documentation and execution.
- DVM with MS or PhD in animal science, microbiology, virology, molecular biology or other biomedical field OR MS in animal sciences, biomedical or related scientific field with appropriate related experiences (>5 years), which could include academic research with a record of publication OR BS in animal sciences, biomedical or related scientific field with appropriate related experiences (>10 years).
Functions, Duties, Tasks:
- Plan, design, coordinate, conduct, oversee, report, analyze and interpret clinical efficacy and/or safety studies required for registration of new products, product line extensions and/or product remediations
- Provide creative and proactive solutions to project teams
- Work with the project team to proactively develop and communicate in a timely manner to management the overall project strategy, budgets, phase transitions, project progress and any delays, key issues, and any other critical topics. Represent the project team at scientific review and portfolio management boards.
- Actively participate in internal and external communications with other scientists to ensure excellence in study design and execution
- Constantly improve knowledge and expertise in state of the art for farm animal clinical trial and target animal safety design and model system development
- Develop and validate models for disease states of interest
- Assist in drafting regulatory submissions and participate during dossier review process
- Complete study documentation in accordance with appropriate quality standards
- Provide information to ensure accurate tracking of project budgets and timelines
- Ensure scientific integrity and animal welfare in all activities
- Attend scientific meetings, continuing education courses and keep abreast of scientific advances and new developments in the animal health industry
- Business and technical knowledge of farm animal vaccines
- Advanced understanding of R&D and regulatory processes
- Proven leadership, communication, organizational and interpersonal skills
- Demonstrated ability to work in an international and cross-functional matrix environment
- Good understanding and working knowledge of GCP / GLP / GMP and quality
- Demonstrated ability to collaborate with external partners
- Demonstrated ability to prioritize and to respond to changing priorities
- Fluent in English (read, write and speak)
- This role allows a flexible location and working normal office hours but might require domestic and international travel up to approximately 5-10%.
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