Principal Clinical Research Scientist - Equipment Platform Vision

Johnson & Johnson Johnson & Johnson · Pharma · Milpitas, CA +2

Principal Clinical Research Scientist role at Johnson & Johnson focused on ophthalmic and medical device research, driving strategic direction for clinical programs and generating scientific evidence for new technologies. Requires expertise in clinical research, new product development, design control, and ophthalmic device regulations.

What you'd actually do

  1. Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs
  2. Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle
  3. Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.)
  4. Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
  5. Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies

Skills

Required

  • Clinical research
  • New product development
  • Design control
  • Ophthalmic device regulations
  • Clinical program strategy
  • Scientific evidence generation
  • Technical writing
  • Biostatistics
  • Computer and software proficiency

Nice to have

  • Software-driven medical devices
  • Capital equipment experience
  • MD with specialty in Ophthalmology
  • Post-graduate degree or residency

What the JD emphasized

  • in-depth understanding of clinical research
  • familiarity with new product development
  • ophthalmic device regulations
  • consistent track record as a key leader and contributor
  • advanced degree in a Scientific Field is required
  • Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend
  • Minimum of 8 years of relevant clinical / scientific work experience
  • Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
  • Understanding of biostatistics as applied to study data is required
  • Ability to travel 10% of the time is required