Principal Scientist, Clinical Research (robotics & Digital Solutions) - Medtech Surgery

Johnson & Johnson Johnson & Johnson · Pharma · Santa Clara, CA +1

This role is for a Principal Scientist in Clinical Research focusing on Robotics & Digital Solutions within MedTech Surgery at Johnson & Johnson. The primary responsibilities involve developing and executing global evidence generation strategies for pre- and post-market approval studies, designing clinical trials, and leading cross-functional teams to interpret and disseminate evidence. The role also supports regulatory submissions and assesses new business development opportunities. While the role is in healthcare and involves technology, it does not corely focus on building AI/ML models.

What you'd actually do

  1. Develop and deliver global evidence generation strategies (pre- and post-market approval studies, investigator initiated, real world evidence) aligned to the needs of R&D, Regulatory, and Commercial.
  2. Ensure input and strong alignment from strategically important regional MedTech leads.
  3. Design clinical trials to meet the premarket and post-market needs.
  4. Strengthen capability in and drive implementation of real-world evidence to deliver efficient evidence solutions.
  5. Develop network with key surgeons in US, EU, and APAC to assist in execution of Robotic Surgery clinical trials for registration in all regions.

Skills

Required

  • Bachelor's degree in Biological Science, Engineering, or a related field
  • 8+ years of related scientific / technical experience within Clinical Research
  • Expertise in clinical research science and processes
  • Broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
  • Proven track record of contributing to clinical programs within a clinical or surgical research setting, on time, within budget, and in compliance with SOPs and US regulations

Nice to have

  • Advanced Degree (Master’s or Ph.D.)
  • Experience working in Robotics
  • Experience in support of global regulatory submissions for medical devices, biologics, or drugs
  • Clinical Site Monitoring experience
  • Clinical Evaluations
  • Coaching
  • Critical Thinking
  • Drug Discovery Development
  • Entrepreneurship
  • Good Clinical Practice (GCP)
  • Leadership
  • Medicines and Device Development and Regulation
  • Organizing
  • Regulatory Affairs Management
  • Relationship Building
  • Research Documents
  • Safety-Oriented
  • Scientific Research
  • Standard Scientific Processes and Procedures
  • Strategic Change
  • Study Management

What the JD emphasized

  • clinical research science and processes
  • product development processes
  • global clinical trial regulations
  • clinical programs within a clinical or surgical research setting
  • US regulations