Senior Scientist, Clinical Development

Biopharma Careers; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

Vacation –120 hours/year

Sick time – 40 hours/year

Holiday pay – 13 days/year

Work, Personal and Family Time – up to

Parental Leave – 480 hours

Bereavement Leave – 240 hours

Volunteer Leave – 32 hours

Military Spouse Time-Off – 80 hours

Job summary

Johnson & Johnson MedTech is recruiting a Senior Scientist, Clinical Research, Robotics & Digital Solutions, to lead evidence generation strategies from Santa Clara, CA or Cincinnati, OH. The role requires 5+ years of clinical research experience and robotics know‑how, with oversight of real‑world evidence and regulatory submissions.

You will collaborate with cross‑functional teams to deliver high‑quality data for regulatory decisions, and may travel up to 25%.

Qualifications

• 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 is required.
• Proven track record of contributing to clinical programs on time, within budget and in compliance to SOPs and regulations is required.
• Experience working in Robotics is preferred.
• May require up to 25% domestic and international travel.

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 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 post market studies
• Execute and oversee mutli‑centre 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, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.

Skills

Clinical research

Regulatory knowledge

Robotics experience

Project leadership

Regulatory submissions

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, 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

Johnson & Johnson MedTech is recruiting for a Senior Scientist, Clinical Research, Robotics & Digital Solutions, located in Santa Clara, California or Cincinnati, Ohio.

Purpose

Johnson & Johnson MedTech has been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies 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 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.

You will be responsible for

• 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 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 post market studies
• Execute and oversee mutli‑centre 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, based on evidence dissemination strategy, 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, including proposed studies; 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 and work effectively in a team‑oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility
• Build successful relationships internally and develop partnerships with key business partners and customers/investigators

Qualifications / 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 is required.
• Proven track record of contributing to clinical programs on time, within budget and in compliance to SOPs and regulations is required.
• 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.

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

• 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.

Equal Opportunity Employer

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.

Accommodations for Disability

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.

Other Eligibility

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

Additional Pay Transparency

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

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