elanco
Senior Research Scientist - Clinical Operations
At a Glance
- Location
- United States of America
- Employment
- Full time
- Posted
- 2026-02-18
Key Requirements
Domain Knowledge
- Clinical
- Medical
- Regulatory
Requirements
• Strong ability to interpret clinical and safety data, combined with excellent verbal and written communication skills to translate complex medical concepts to investigators, pet owners, and cross-functional partners.
• Working knowledge of VICH GL9 Good Clinical Practice and familiarity with FDA CVM guidance for companion-animal field effectiveness studies.
• Understanding of U.S. regulatory frameworks for veterinary medicinal products, including FDA CVM, USDA APHIS CVB, and EPA where applicable.
Nice to have:
• Prior experience in veterinary clinical research.
Responsibilities
As Medical Monitor, you will serve as the medical and safety, lead for U.S. companion-animal clinical trials involving client-owned animals. In this role, you will provide veterinary oversight to support clinical development and product registration, ensuring studies are conducted in alignment with FDA CVM, USDA APHIS CVB, EPA (where applicable), VICH GL9 Good Clinical Practice, and pharmacovigilance requirements, while safeguarding animal welfare and study integrity.
• Provide medical leadership for assigned clinical studies, including protocol design input, oversight of patient populations and endpoints, and expert support to investigators and site staff.
• Serve as the primary medical and safety contact, leading adverse event review and risk-benefit assessment while ensuring accurate reporting and coding (e.g., VeDDRA, ATCvet, ABON) in partnership with R&D project teams
• Ensure compliance with study protocols and business requirements, including, medical oversight and training for study sites.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, Statistics & Data Management, Regulatory Affairs, and Animal Welfare to drive study execution and regulatory compliance.
• Contribute to clinical development plans, lifecycle decisions, and data system improvements, integrating medical insight into audit responses, EDC processes, and overall study quality.