Principal Scientist - Preclinical, Robotics & Digital Solutions - MedTech Surgery

Antler; Cincinnati (OH); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

Pension plan

401(k) savings plan

Long-term incentive program

Job summary

Johnson & Johnson is seeking a Principal Scientist in Preclinical for MedTech Surgery Robotics in Cincinnati, OH. This on-site role requires a strong background in preclinical research, GLP experience, and regulatory coordination with global teams.

You will lead global preclinical strategies, design studies, and act as Study Director while collaborating with cross-functional partners to advance regulatory submissions and product development. Domestic and international travel may be required.

Qualifications

• Bachelor's degree in Biological Science or related field is required.
• Advanced degree (MS/PhD) preferred.
• Experience with FDA 21 CFR part 58 (GLP) required.
• Minimum 8 years of related preclinical research experience.
• Experience supporting regulatory submissions for medical devices.

Responsibilities

• Develops and delivers global preclinical evidence generation strategies aligned to R&D, Regulatory, and Commercial needs.
• Designs, plans and executes preclinical animal studies for safety, performance, and effectiveness; includes protocol development and reports.
• Acts as Study Director for GLP and non-GLP studies as defined in 21 CFR part 58.
• Supports regulatory discussions with agencies to drive preclinical and regulatory strategy.
• Builds relationships with internal partners and investigators; mentors staff where applicable.
• Travel up to 15% domestically and internationally.

Skills

Clinical Evaluations

Leadership

Regulatory Affairs

GCP

Education

Bachelor's degree in Biological Science

MS/PhD preferred

Job description

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

Job Description

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, 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.

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

We are searching for the best talent for a Principal Scientist, Preclinical, Robotics & Digital Solutions, located in Cincinnati, Ohio. This will be an on-site position and we are open to candidates willing to relocate. This role may require up to 15% domestic and international travel.

Purpose

This position has the unique opportunity to support Preclinical activities within the Johnson & Johnson MedTech Surgery Robotics program. Johnson & Johnson MedTechJohnson & 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 aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. 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.

This position will serve as a scientific contributor for the development and execution of preclinical evidence strategies necessary to competitively position a product for domestic and international regulatory and clinical acceptance.

You Will Be Responsible For

• Develops and delivers appropriate global preclinical evidence generation strategies aligned to R&D, Regulatory, and Commercial needs
• Ensures input and strong alignment from key regional MedTech leads and other strategically important countries/regions in the development of the preclinical and clinical evidence generation strategies
• Contributes and supports the design of appropriate studies to meet pre-market and post-market needs
• Designs, plans and executes preclinical animal studies for the assessment of safety, performance, and effectiveness; includes study and IACUC protocol development and final reports
• Acts as Study Director as defined in 21 CFR part 58 for GLP and non-GLP studies
• Assesses, communicates, and manages the risks associated to the preclinical evaluation of products
• Ensures appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.
• Supports preclinical scientific discussions with regulatory agencies / notified bodies to drive support of the preclinical, and regulatory strategy, including proposed studies; review process of evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections
• Demonstrates the ability to influence, shape and lead teams and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility
• Builds successful relationships internally and develop partnerships with key business partners and customers/investigators
• For those who supervise or manage a staff, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

Qualifications / Requirements

• A minimum of a bachelor’s degree in Biological Science or a related discipline is required. An advanced degree (master’s or Ph.D.) is preferred
• Working knowledge and application of FDA 21 CFR part 58 (GLPs)
• A minimum of 8 years of related scientific / technical experience within preclinical research is required
• Experience in preclinical science and processes along with an understanding of medical device development processes, related healthcare market environment, and preclinical regulations is required
• Proven track record of contributing to preclinical programs on time, within budget and in compliance to SOPs and regulations is required
• Experience working in a GLP environment and direct experience executing preclinical GLP studies
• Understanding of good documentation practices
• Familiarity with animal welfare regulations and IACUC
• Experience in support of global regulatory submissions for medical devices, [including IDE/De Novo/510(k)] and/or their global counterparts)
• May require up to 15% domestic and international travel

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.

Benefits

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

Required 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

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 :

$117,000.00 - $201,250.00