Principal Scientist, Clinical Research - MedTech Surgery

Johnson & Johnson MedTech; Cincinnati (OH); On-site; USD 134,000 - 231,000; Full time

Benefits offered by this job

Vacation – 120 hours/year

Parental Leave – 480 hours/year

Volunteer Leave – 32 hours/year

Job summary

Johnson & Johnson MedTech is seeking a Principal Scientist, Clinical Research, Robotics & Digital Solutions to lead global evidence generation for the Robotic Surgery Platform. You will collaborate with Medical, Clinical, Regulatory, and Commercial teams to design trials and deliver real-world evidence across regions.

The role requires a strong background in clinical research within medical devices or robotics, with leadership experience and up-to-date knowledge of regulatory expectations,

Qualifications

• Minimum 8 years of related scientific/technical experience within Clinical Research.
• Bachelor's degree in Biological Science, Engineering, or related field required; advanced degree preferred.
• Expertise in clinical research science and processes along with understanding of product development processes and global clinical trial regulations.

Responsibilities

• Develop and deliver global evidence generation strategies (pre- and post-market studies, real-world evidence).
• Design clinical trials to meet premarket and post-market needs.
• Lead cross-functional teams to interpret and disseminate evidence (CSRs, abstracts, manuscripts).
• Support regulatory discussions and review processes for marketing authorization and line extensions.

Skills

Clinical research

Regulatory understanding

Team leadership

Robotics experience

Education

Bachelor's degree in Biological Science or Engineering

Advanced degree (Master’s or Ph.D.)

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Clinical Development & Research – Non-MD

Job Category

Scientific/Technology

All Job Posting Locations

Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America

Job Description

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that’s reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://jnjmedtech.com

Purpose

Johnson & Johnson MedTech has been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we seek to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our vision is to use digital technology across the episode of care to improve surgical efficiency, promote better clinical outcomes and increase patient satisfaction. In this position, you will provide scientific leadership for Johnson & Johnson MedTech Surgery's Robotic Surgery Platform, collaborating closely with multi-functional evidence teams, including Medical, Clinical, Pre-clinical and Health Economics and Market Access.

We are searching for the best talent for a Principal Scientist, Clinical Research, Robotics & Digital Solutions, located in either Santa Clara, California or Cincinnati, Ohio. This is an on-site position that may require up to 25% domestic travel.

You Will Be Responsible For

• 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
• Ensure input and strong alignment from strategically important regional MedTech leads
• Design clinical trials to meet the premarket and post-market needs
• Strengthen capability in and drive implementation of real-world evidence to deliver efficient evidence solutions
• Develop network with key surgeons in US, EU, and APAC to assist in execution of Robotic Surgery clinical trials for registration in all regions
• Lead cross-functional teams to interpret and disseminate evidence, including CSRs, abstracts, manuscripts, etc.
• Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections
• Provide scientific, technical, and strategic assessment of new business development opportunities and support acquisition of innovative products
• Demonstrate the ability to influence, shape and lead teams
• Build successful relationships internally and develop partnerships with key business partners and customers/investigators
• May require up to 25% domestic travel.

Qualifications / Requirements

• A minimum of a Bachelor’s degree in Biological Science, Engineering, or a related field is required. An advanced degree (Master’s or Ph.D.) is preferred.
• A minimum of 8 years of related scientific / technical experience within Clinical Research required
• Expertise in clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations required
• 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 is required

Preferred

• Experience working in Robotics strongly preferred
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check

Preferred Skills

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

The anticipated base pay range for this position is :

$134,000.00 - $231,150.00