Principal Research Scientist

Role Summary

Principal Research Scientist responsible for conducting groundbreaking clinical research to develop novel animal health products. You will design and validate cell-based in vivo and in vitro bioassays, develop pharmacokinetic and pharmacodynamic biomarker assays, and transfer knowledge from research to development and launch while adhering to company-wide standards. You will manage multiple research projects and supervise a team, with 25% domestic and international travel.

Responsibilities

• Responsible for conducting groundbreaking clinical research, all with the goal of developing novel, effective animal health products.
• Conceptualize, design, construct, and validate cell based in vivo and in vitro bioassays to screen activity and potency of proprietary biotherapeutic and vaccine molecules.
• Conceptualize, design, construct, and validate cell based in vitro anti-drug antibody assays.
• Develop pharmacokinetic and pharmacodynamic biomarker assay reagents and assays, including providing subject matter expertise on the development of biopharmaceutical pre-clinical and clinical pharmacology flow schemes.
• Keep abreast of scientific developments and integrate these into research and development projects.
• Provide expertise in evaluating new platform technologies; determine technologies best suited to meet Elanco’s needs.
• Proactively search for novel technologies or product opportunities; establish collaborations and research programs to deliver innovative technical solutions.
• Transfer knowledge from research to development, development to registration, and registration to launch, including preparing internal and external publications; follow company standards and best practices.
• Analyze Elanco’s current product offerings and identify areas for further research and development.
• Manage and oversee multiple research projects, ensuring adherence to standards, protocols, and best practices.
• Supervises 8 subordinates: Consultants and Senior Research Scientists.

Qualifications

• Required: Bachelor’s degree in Veterinary Science, Veterinary Medicine, Animal Science, a related field, or foreign equivalent, plus 5 years of progressively responsible post-baccalaureate experience in the offered position or related job titles.
• Experience includes: clinical product development including regulatory requirements for drug, vaccine, and parasitology; conducting GCP and GLP studies; obtaining approval for parasitology, small molecule drug, and vaccine projects; team management; technical writing for regulatory submissions/publications; developing clinical regulatory strategy; and parasitology technologies for farm animals.
• Travel: 25% domestic and international travel for project planning and external meetings.

Skills

• Clinical product development with regulatory experience for drugs, vaccines, and parasitology
• GCP and GLP study execution
• Development of regulatory strategies for clinical programs
• Parasitology technologies and applications in farm animals
• Technical writing for regulatory submissions and scientific publications
• Team leadership and project management
• Identification and evaluation of new platform technologies
• Collaborations and research program development

Education

• Bachelor’s degree in Veterinary Science, Veterinary Medicine, Animal Science, or related field; foreign equivalent accepted

Additional Requirements

• Location: 450 Elanco Circle, Indianapolis, Indiana, 46221
• Travel: 25% domestic and international