Elanco · 6 hours ago
Principle Research Scientist - Clinical Operations
Indianapolis, IN
Full-time
Hybrid
Senior Level, Lead/Staff
5+ years expElanco is a global leader in animal health dedicated to innovation and delivering products to prevent and treat diseases in farm animals and pets. The Principal Research Scientist in Clinical Operations will conduct and coordinate global clinical development programs, ensuring compliance with regulatory standards and collaborating with various departments to advance Elanco's innovation pipeline.
ManufacturingPetSupply Chain Management
Responsibilities
Plan, coordinate, implement, and report high-quality clinical effectiveness and TAS programs to support development of new parasiticide products for pets and farm animals, including pilot and pivotal studies conducted in compliance with global regulatory standards and guidelines such as GLP, vGCP, and VICH
Formulate comprehensive clinical development plans for new products and build effective cross-functional relationships across Portfolio and Project Leadership, Regulatory Affairs and Pharmacovigilance, Clinical Development Sciences (CDS), R&D Quality Assurance, Marketing, Manufacturing, and Quality to ensure timelines and quality expectations (GCP, GLP) are met throughout development and lifecycle management
Execute individual clinical programs in collaboration with CDS, Biostatistics, and Regulatory Affairs, including designing and authoring protocols for laboratory and field efficacy studies and TAS studies to support regulatory approvals
Work with CDS to select appropriate internal research sites or external Contract Research Organizations (CROs) and qualified investigators to execute study protocols
Coordinate study monitoring activities to ensure compliance with applicable regulations, company policies, and management expectations
Analyze and interpret study results with support from Data Management, Medical Writing, Biostatistics, and internal or external subject matter experts, and author high-quality study reports
Partner with Regulatory Affairs to prepare clinical reports and datasets for submission to regulatory agencies and present data to regulatory authorities and scientific meetings
Ensure quality assurance and regulatory compliance and participate in or lead development of new processes and functional procedures
Attend scientific meetings and continuing education programs and remain current on scientific advances in the animal health industry and veterinary profession
Qualification
Required
DVM or PhD in an animal health–related field preferred. An MS with relevant experience will be considered. An advanced degree (PhD) in parasitology in addition to a DVM is desirable
Five or more years of experience in product development within or closely associated with the pharmaceutical industry preferred
Demonstrated ability to organize and manage multiple projects simultaneously with strong attention to detail
Knowledge of applicable global, national, and federal regulations governing parasiticide product evaluation
Working knowledge of word processing and spreadsheet software
Self-motivated, with the ability to work and learn independently
Excellent written and verbal communication skills
Preferred
Basic understanding of research and development processes
Experience acting as a strategist and facilitator to advance clinical programs
Proven experience working with regulatory authorities
Strong understanding and working knowledge of GCP, GLP, GMP, and quality systems
Demonstrated ability to collaborate effectively with external partners and CROs
Evidence of achievement across key competencies including Strategic Mindset, Business Insight, Cultivating Innovation, and Driving a Vision
Company
Elanco
Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.
5001-10000 employees
H1B Sponsorship
Elanco has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
Funding
Current Stage
Public CompanyTotal Funding
$252.86MKey Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M
Leadership Team
Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
Jennifer Black
Senior Director, Global Indirect Procurement
Recent News
2026-01-03
2025-12-18
Company data provided by crunchbase