Principal Clinical Research Scientist - Surgical Implants Vision

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

Principal Clinical Research Scientist role in Surgical Implants Vision at Johnson & Johnson. Focuses on driving strategic direction for clinical programs, generating scientific evidence for new technologies, and understanding clinical research, new product development, and ophthalmic device regulations. Requires an advanced scientific degree, 8+ years of experience, and strong technical writing skills.

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

  • Advanced degree in a Scientific Field
  • Minimum of 8 years of relevant clinical / scientific work experience
  • Leadership functions experience
  • Strong technical writing ability
  • Understanding of biostatistics
  • Proficient with computers and software programs
  • Ability to travel 10% of the time

Nice to have

  • Doctoral Degree-Optometry or MD with specialty in Ophthalmology
  • Post-graduate degree or residency
  • Experience with intraocular lenses

What the JD emphasized

  • core team member on critical projects
  • in-depth understanding of clinical research
  • familiarity with new product development
  • ophthalmic device regulations
  • strong technical writing ability
  • understanding of biostatistics
  • Proficient with computers and software programs