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: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
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.
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
#LI-Onsite
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 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
Additional Description for Pay Transparency:
