The Global Clinical Development – Farm Animal (FA) Research Scientist is responsible for the strategy, design, and conduct of clinical effectiveness and safety programs for global FA development projects. The role has the following core responsibilities within global food animal therapeutics, nutritional, parasitology, and biopharma clinical development:
- Ensure the collection of accurate and complete datasets of safety and efficacy studies in compliance with the required global regulatory standards and guidelines.
- Contribute as a clinical subject matter expert (SME) to and/or lead clinical project teams for the development and licensure of global food animal therapeutic projects.
- Contribute as a clinical SME to and/or lead product line extension and/or product remediation projects.
Please Note: We will consider Remote/Teleworker for this position
This role necessitates developing and maintaining strong relationships with functional partners in manufacturing, regulatory affairs, quality, commercial and other areas of research and development (R&D).
Basic Minimum Qualifications:
- Familiar with GCP / GLP study documentation and execution.
- DVM with MS or PhD in animal science, pharmacology, or other biomedical field OR PhD in animal science, pharmacology, 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:
- 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 communication 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
- Design, implement, and oversee appropriate clinical efficacy and / or safety studies
- Development and validation of models for disease states of interest
- Assist in drafting regulatory submissions and participate during dossier review process
- Direct involvement in discussions with global regulatory authorities in planning and implementation of development programs
- 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.
- Technical expertise in ruminant nutrition and/or sustainability
- Advanced understanding of research and development processes
- Excellent communication and interpersonal skills
- Demonstrated ability to lead effectively cross-functional processes
- Acting as strategist and facilitator to drive clinical programs
- Proven experience working with regulatory authorities
- Good understanding and working knowledge of GCP/GLP/GMP and quality
- Demonstrated ability to collaborate with external partners
- Some travel required (domestic and international)
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