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Jobs · Analyst · California

Senior Scientist, Clinical Development

Johnson & Johnson MedTech · Santa Clara, CA · 1 wk ago
On-siteAnalyst$125k–$201k/yrFull-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.

About the Role

Johnson & Johnson MedTech Surgery is recruiting for a Senior Scientist, Clinical Research, Robotics & Digital Solutions, located in Santa Clara, California or Cincinnati, Ohio. This unique position will serve as a scientific contributor for the development and execution of clinical research necessary to competitively position a product for domestic and international regulatory and clinical acceptance.

Johnson & Johnson’s long-term vision is to use digital technology as part of a holistic approach to surgery across the episode of care to enhance surgical efficiency, promote better clinical outcomes, and increase patient satisfaction. You will help develop the next generation of smarter, less invasive, more personalized surgical treatments, impacting prevalent conditions such as obesity, cardiovascular disease, and cancer.

Responsibilities

  • Develop and deliver appropriate global evidence generation strategies (premarket studies, postmarket studies, investigator initiated, real world evidence) aligned to R&D, Regulatory, and Commercial needs
  • Ensure input and strong alignment from key regional MedTech leads and other strategically important countries/regions in the development of clinical evidence generation strategies
  • Contribute to and support the design of appropriate studies to meet premarket and postmarket needs
  • Review, analyze, and present current literature on real-world evidence (RWE) studies
  • Meet US and EU regulatory requirements for postmarket studies
  • Execute and oversee multi-center clinical trials to meet milestones
  • Strengthen capability in and drive implementation of real-world evidence to deliver cost-effective evidence solutions
  • Ensure appropriate interpretation and dissemination of all evidence generated, including study reports, abstracts, manuscripts, etc.
  • Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical, preclinical, and regulatory strategy
  • Review process of evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections
  • Demonstrate the ability to influence, shape, and lead teams in a team-oriented environment that embraces ownership, accountability, innovation, change, risk, and flexibility
  • Build successful relationships internally and develop partnerships with key business partners and customers/investigators

Requirements

  • A minimum of 5 years of related scientific/technical experience within clinical research is required
  • Experience in clinical science and processes along with an understanding of product development processes, related healthcare market environment, clinical trends, and/or clinical trial regulations
  • Proven track record of contributing to clinical programs on time, within budget, and in compliance with SOPs and regulations
  • Experience working in Robotics is preferred
  • Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred
  • May require up to 25% domestic and international travel

Benefits

  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
  • This position is eligible to participate in the Company’s long-term incentive program
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
  • Holiday pay, including Floating Holidays – 13 days per calendar year
  • Work, Personal, and Family Time – up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year

Pay

The anticipated base pay range for this position is $125,000.00 - $201,250.00.

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