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Principal Research Scientist

Elanco
Full-time
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development

Role Summary

Principal Research Scientist responsible for conducting groundbreaking clinical research to develop novel, effective animal health products. Lead design and validation of bioassays, develop pharmacokinetic/pharmacodynamic biomarker assay reagents, monitor scientific developments, evaluate new technologies, transfer knowledge across stages, analyze current offerings for new opportunities, and oversee multiple research projects while supervising a team.

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 Elanco’s 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 in the field and integrate these novel developments into our research and development projects.
  • Provide expertise and specialized knowledge in the evaluation of new platform technologies; determine which technologies and processes are best suited to meet Elanco’s unique needs.
  • Proactively search for novel technologies or product opportunities; use specialized knowledge to establish collaborations and research programs to deliver innovative technical solutions.
  • Transfer knowledge and information from research to development, from development to registration, and from registration to launch, including the preparation of internal and external publications; ensure each step follows Elanco’s company-wide 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 that each project adheres to Elanco’s 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 a foreign equivalent, plus 5 years of progressively responsible post-baccalaureate experience in a related role.
  • Experience in clinical product development including regulatory requirements for drug, vaccine, and parasitology; conducting GCP and GLP studies; obtaining approvals 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.
  • 25% domestic and international travel required for internal and external meetings related to project planning and implementations.

Skills

  • Biotherapeutics and vaccine development
  • Cell-based assay design and validation (in vitro and in vivo)
  • Antibody assay development (anti-drug antibodies)
  • Pharmacokinetic/pharmacodynamic assay development
  • Regulatory clinical development and GxP (GCP/GLP) knowledge
  • Technical writing and publication preparation
  • Strategic evaluation of platform technologies
  • Project management and cross-functional collaboration

Education

  • Bachelor’s degree in Veterinary Science, Veterinary Medicine, Animal Science, or related field (foreign equivalent acceptable).

Additional Requirements

  • Travel: 25% domestic and international travel expected for project planning and partner meetings.
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