Principal Research Scientist - Clinical Operations

Elanco; Indianapolis (IN); Híbrido; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

Two weeklong shutdowns (US)

8-week parental leave

Employee Resource Groups

Annual bonus offering

Flexible work arrangements

401K matching

Descripción de la vacante

Elanco, a global leader in animal health, seeks a Principal Research Scientist for Pet Health Clinical Development in Dermatology and Therapeutics. You will plan and execute global clinical programs from inception to regulatory approval, coordinating with CDS, Regulatory Affairs, and external CROs to ensure high quality deliverables.

Ideal candidates hold a DVM or PhD in animal health, with 5+ years in product development and a strong track record in GCP/GLP/GMP, scientific writing, and

Formación

• DVM or PhD preferred in animal health; MS considered.
• Experience in product development within pharma is preferred.
• Strong organization and communication skills; ability to manage multiple projects.

Responsabilidades

• Formulate clinical development plans for new products.
• Design and write protocols for efficacy studies to regulatory approval.
• Coordinate with CDS, Regulatory Affairs, Biostatistics and external partners.
• Analyze results and author study reports for submission to authorities.
• Prepare reports and data for regulatory submissions and meetings.

Conocimientos

Project management

Regulatory knowledge

GCP/GLP/GMP

Scientific writing

Cross-functional collaboration

Educación

DVM or PhD in animal health

MS considered

Descripción del empleo

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

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 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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.