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Johnson & Johnson Logo

Principal Scientist

Johnson & Johnson

Salary not specified
Apr 15, 2025
Cincinnati, OH, US
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The company is looking to develop and execute strategies for preclinical evidence to competitively position products for domestic and international regulatory approval and clinical adoption.

Requirements

  • Knowledge of medical device regulations, regulatory/notified body requirements
  • Extensive knowledge of Preclinical Research
  • Knowledge of US FDA and other international regulations related to preclinical research
  • Experience with non-clinical research in a medical device or pharmaceutical industry setting
  • Ability to clearly document and communicate plans and results
  • Business acumen and experience, including skills in budgeting, resource management, and staff development

Responsibilities

  • Design, execute, analyze and interpret non-clinical studies to understand the safety and efficacy of product conceptual to final designs
  • Create the non-clinical strategy and testing plan, as well as oversee study execution per project timelines
  • Assess, communicate, and manage the risks associated with the non-clinical evaluation of product concept for projects to ensure success
  • Develop and modify preclinical models as needed to meet product requirements
  • Serve as the preclinical subject matter expert for projects at First in Human Committee consultations and reviews
  • Perform the role as designated Study Director for all types of non-clinical studies performed internally
  • Identify external vendor, as needed, to execute non-clinical studies

Other

  • A minimum of a Master’s Degree in biomedical engineering or a related discipline is required
  • Doctorate degree in biomedical engineering or a related discipline, or veterinary medicine is preferred
  • At minimum 8 years of experience in non-clinical research in a medical device or pharmaceutical industry setting
  • Excellent communication skills – written/oral/listening
  • Ability to lead and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility
  • Up to 20% travel required