Senior Research Scientist - Clinical Operations

Role Summary

Medical Monitor (R2/R3) leading U.S. companion-animal clinical trials involving client-owned animals. 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.

Responsibilities

• 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.

Qualifications

• Required: Doctor of Veterinary Medicine (DVM or equivalent) from an AVMA-accredited veterinary school; licensed or eligible for licensure in at least one U.S. state.
• Required: Clinical experience in small animal practice
• Required: 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.
• Required: Working knowledge of VICH GL9 Good Clinical Practice and familiarity with FDA CVM guidance for companion-animal field effectiveness studies.
• Required: Understanding of U.S. regulatory frameworks for veterinary medicinal products, including FDA CVM, USDA APHIS CVB, and EPA where applicable.
• Preferred: Prior experience in veterinary clinical research.
• Preferred: Experience supporting companion-animal or field-based clinical trials.
• Preferred: Exposure to pharmacovigilance systems and adverse event coding standards.
• Preferred: Experience participating in regulatory inspections or quality audits.
• Preferred: Demonstrated ability to lead cross-functional medical discussions and influence clinical risk assessments.

Additional Requirements

• Travel: Periodic domestic travel required for investigator meetings, key site visits, cross-functional workshops, and scientific or regulatory meetings.
• Location: Indianapolis HQ