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 SurgeryFueled 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 Surgery is recruiting for a Senior Scientist, Clinical Research, Robotics & Digital Solutions,
located in Santa Clara, California or Cincinnati, Ohio.
Purpose: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 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.
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.
Required Skills:Preferred Skills:Clinical Data Management, Clinical Evaluations, Coaching, Critical Thinking, Data Savvy, Drug Discovery Development, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Industry Analysis, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Technologically Savvy
The anticipated base pay range for this position is :$125,000.00 - $201,250.00
Additional Description for Pay Transparency:
