Principal Scientist, Preclinical Research

mpact health for humanity. Learn more at https://https://www.jnj.com

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:

We are searching the best talent for a Principal Scientist, Preclinical Research, Robotics & Digital Solutions to join our MedTech Surgery Team located in Cincinnati, OH or Santa Clara, CA.

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 surgery? Ready to join a team that's reimagining how we heal? Our 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://https://www.jnj.com/medtech

Purpose:

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 preclinical and clinical evidence strategies necessary to competitively position a product for domestic and international regulatory and clinical acceptance.

You will be responsible for:

• Develop and deliver appropriate global preclinical evidence generation strategies 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 the preclinical and clinical evidence generation strategies

• Contribute and support the design of appropriate studies to meet pre-market and post-market needs

• Design, plan and execute preclinical animal studies for the assessment of safety, performance, and effectiveness; includes study and IACUC protocol development and final reports

• Act as Study Director as defined in 21 CFR part 58 for GLP and non-GLP studies

• Assess, communicate, and manage the risks associated to the preclinical evaluation of products

• Ensure appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.

• Support 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

• 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:

Education:

• 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

Required:

• A minimum of 8 years of related scientific / technical experience within preclinical research

• Experience in preclinical science and processes along with an understanding of medical device development processes, related healthcare market environment, and preclinical regulations

• Proven track record of contributing to preclinical programs on time, within budget and in compliance to SOPs and regulations

Preferred:

• Experience working in Robotics

• 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)

Other:

• Must be able to commute into the Cincinnati, Ohio or Santa Clara, CA

• Ability to travel up to 15%, domestic and international

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 and 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 email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$115,000-$180,000. California Bay Area $130,000-$220,000
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be 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. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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 and 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 email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.