Principal Research Scientist - Clinical Operations
Elanco
Summary
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.
Job description
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
Requirements
- DVM or Ph.D. in an animal health related field preferred; MS with experience considered
- Minimum of 5 years of experience in product development within or closely associated with the pharmaceutical industry preferred
- Outstanding organization, motivation and communication skills
- Ability to organize and manage a variety of projects at any one time with 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
- Basic understanding of research and development processes
- Good understanding and working knowledge of GCP/GLP/GMP and quality
- Proven experience working with regulatory authorities
- Demonstrated ability to work with external partners
Benefits
- Relocation packages
- Two weeklong shutdowns
- Parental leave
- Employee resource groups
- Annual bonus
- Flexible work arrangements
- 401(k) matching
Company overview
Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.