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US - Teleworker, United States of America
Onsite
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Job Description
Position Description This is not a bench research, laboratory, or basic discovery role. This is a high-visibility, execution-focused Clinical Operations leadership role.
The Senior Scientist – Clinical Operations is fully responsible for the operational planning, vendor oversight, and hands-on execution of Target Animal Safety (TAS) and effectiveness studies. You will act as the primary Study Director or Sponsor Monitor, ensuring that trials conducted through external Contract Research Organizations (CROs) and field sites are delivered on time, within budget, and in strict compliance with regulatory standards. If your background is strictly in data analysis, lab work, or academic research without direct clinical trial project management and vendor oversight, this role is not aligned.
Key Responsibilities
Operational Study Ownership: Lead the operational end-to-end execution of TAS and effectiveness studies, moving trials seamlessly from concept protocol to final study report.
Vendor & CRO Management: Serve as the primary point of contact for CROs, university research sites, and private investigators. Manage site selection, study timelines, protocol deviations, and vendor accountability.
Protocol & Document Management: Author, review, and refine clinical study protocols, amendments, and data collection forms ensuring operational feasibility.
Compliance & Quality: Ensure all study activities rigidly adhere to FDA-CVM, VICH, GLP, and GCP guidelines. Monitor data integrity and troubleshoot field execution issues in real-time.
Cross-Functional Collaboration: Partner directly with Regulatory Affairs, Biostatistics, and Formulation R&D to translate scientific strategy into flawless operational execution.
Minimum Qualifications
Ph.D., DVM, or Master’s/Bachelor’s degree in Animal Science, Toxicology, Pharmacology, Physiology, or a related scientific/clinical discipline with equivalent years of direct trial management experience.
Experience: 5+ years of hands-on clinical trial operations or study management specifically within the Animal Health industry or a veterinary-focused CRO.
Study Expertise: Demonstrated experience managing Target Animal Safety (TAS) and/or pivotal target animal effectiveness studies.
Vendor Oversight: Proven track record of directly managing external partners, CROs, or clinical investigators.
Regulatory Knowledge: Robust, working knowledge of FDA-CVM regulations, GLP, and GCP requirements for veterinary species.
Preferred Qualifications
Direct experience acting as a Study Director or Sponsor Monitor for regulated target animal studies.
Experience across multiple veterinary species (companion animals and livestock/food animal species).
A proven background in troubleshooting clinical field trial logistics (e.g., shipping, site non-compliance, unexpected animal health events).
Experience authoring or contributing directly to technical sections for regulatory submissions (e.g., INAD/NADA files).
What You Will Gain
Full ownership of study execution in a focused animal health environment
Direct impact on safety and effective decisions tied to product development
High visibility across R&D, regulatory, and external partners
Opportunity to work on multi-species programs with real-world application
A role built for execution, not bench or discovery work
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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
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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.