Principal Scientist - Preclinical, Robotics & Digital Solutions - MedTech Surgery
About The Position
This position has the unique opportunity to support Preclinical activities within the Johnson & Johnson MedTech Surgery Robotics program. 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 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.
Requirements
- A minimum of a bachelor’s degree in Biological Science or a related discipline is required.
- 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)
Nice To Haves
- An advanced degree (master’s or Ph.D.) is preferred
Responsibilities
- 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
Benefits
- 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.
- 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 period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Principal
