Principal Research Scientist - Clinical Operations

Indiana Ag Connection; Indianapolis, Northern (IN, KY); Hybrid; USD 140,000 - 185,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (mid-summer & y

Parental leave

401K matching

Flexible work arrangements

Job summary

Elanco, headquartered in Indianapolis, IN, seeks a Principal Research Scientist in Clinical Operations to lead global pet health clinical development programs. You will plan pilot and pivotal studies, author protocols and reports, and select sites or CROs to conduct trials, ensuring GCP/GMP compliance and timelines.

You will report to the Clinical Leader, coordinating with CDS, Regulatory Affairs, and other functions to deliver strong data packages for regulatory approval and product lifecycle

Qualifications

• Strong organizational skills and ability to manage multiple projects.
• Excellent written and verbal communication across teams and stakeholders.
• Knowledge of global regulatory frameworks (GCP/GLP/GMP) and regulatory authorities.

Responsibilities

• Formulate clinical development plans for new products.
• Design and write protocols for lab and field efficacy studies.
• Coordinate with CDS and Regulatory Affairs to prepare regulatory submissions.
• Ensure QA/regulatory compliance and drive process improvements.
• Present data to regulatory authorities and at scientific meetings.

Skills

Organization skills

Communication skills

Regulatory knowledge

Education

DVM or PhD in animal health

MS with experience considered

Job description

### Job Details#### Job Title:Principal Research Scientist - Clinical Operations#### Location:,, ,#### Company:#### Industry Sector:#### Industry Type:#### Career Type:#### Job Type:Full Time#### Minimum Years Experience Required:N/A#### Salary:### Get Job Alerts**Career Type:****Country:** USAI agree to receive alerts from and to the .Your alert was created successfully.x## General Alert Saved* The listings below are jobs matching the criteria you've selected for your General Alert on.Criteria selected was:* General alert saved for .* General alert notifications will be sent weekly on Monday.* Please note that you can only have one general alert active at any given time. Creating a new general alert will override an existing general alert.* Visit the to manage your alerts# Principal Research Scientist - Clinical Operations| Number of Years Experience: | Minimum Education Completed: | || Education Major / Discipline Category: | Most Recent / Current Occupation: | |**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!**As Principal Research Scientist, Pet Health Clinical Development, Dermatology and Therapeutics, you will conduct and coordinate the development of global Pet Health clinical development programs (primarily effectiveness) from their inception through approval in initial target geographies. Specifically, this person will plan and execute pilot and pivotal studies in compliance with global regulatory standards (principally vGCP & VICH) and guidelines. It involves authoring of study protocols and reports, selecting internal sites or Contract Research Organizations (CROs) to conduct studies, coordination, and managing studies.Reporting to the Clinical Leader, the incumbent will have the opportunity to design and execute studies that will deliver Elanco's innovation pipeline to customers.**Your Responsibilities:*** Formulate comprehensive clinical development plans for each new product. Build effective relationships within and outside Research and Development (Portfolio and Project Leadership, Regulatory Affairs and Pharmacovigilance, Clinical Development Sciences (CDS), R&D Quality Assurance, Marketing, Manufacturing and Quality) during development of products and life cycle management to assure that all parties involved meet critical deadlines and deliver work with appropriate quality attributes (GCP, GLP).* Specific duties include executing individual clinical programs. In cooperation with other teams (i.e. CDS, Biostatistics, Regulatory Affairs), design and write protocols for laboratory and field efficacy studies to generate information that will lead to regulatory approval of products. Work cooperatively with CDS to select suitable research facilities and qualified researchers to execute protocols. Coordinate with other teams to ensure study monitoring according to current applicable regulations, company policies, and management expectations. With support from other teams (i.e. Data Management, Medical Writing, Biostatistics, and internal / external SME reviewers), analyze and interpret results and author study reports. Work collaboratively with Regulatory Affairs to prepare reports and data for submission to regulatory agencies and present data to regulatory authorities and/or scientific meetings.* Ensure quality assurance/regulatory compliance and participate and/or lead administrative and procedural activities such as development of new processes and / or functional procedures.* Attend scientific meetings, continuing education courses and keep abreast of scientific advances and new developments in the animal health industry and veterinary profession.**What You Need to Succeed (minimum qualifications):*** **Education**: A DVM or a Ph.D. in an animal health related field is preferred. An MS with experience will be considered.* **Experience**: A minimum of 5 years of experience in product development within or closely associated with the pharmaceutical industry is preferred.* **Outstanding organization, motivation and communication**: ability to organize and manage a variety of projects at any one time demonstrating strict attention to detail; self-motivated and able to work and learn without direct supervision* **Current knowledge of all pertinent global / national / federal regulations** under which therapeutic products are evaluated**What will give you a competitive edge (preferred qualifications):*** Basic understanding of research and development processes* Acting as strategist and facilitator to drive clinical programs* Good understanding and working knowledge of GCP/GLP/GMP and quality; proven experience working with regulatory authorities* Demonstrated ability to work with external partners* Experience and displayed achievements within the key competencies of Strategic Mindset, Business Insight, Cultivating Innovation, and Driving a Vision**Additional Information:*** Travel: < 25%* Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment**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 matchingElanco 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 statusElanco 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.#LI-MW1Elanco 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 statusElanco 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.To apply please click on APPLY TO THIS POSITIONJob Post Date: 09/22/26Here are some other jobs you may be interested in applying for.| | || - | - || Elanco Indianapolis, Indiana | Elanco Indianapolis, Indiana || Elanco Indianapolis, Indiana | |3