Sr Scientist Clinical and Preclinical
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at 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:
US052 OH Cincinnati - 4545 Creek Rd, US328 CA Santa Clara - 5490 Great America Pkwy
Job Description:
Johnson & Johnson MedTech Surgery is recruiting for a Sr Scientific Clinical and Sr. Scientist Clinical and Preclinical Development, for Robotics & Digital Solutions, located in Santa Clara, California or Cincinnati, Ohio. This position has the unique opportunity to support Preclinical and Clinical activities within the Johnson & Johnson MedTech Surgery Robotics program.
Johnson & Johnsons 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.
Responsibilities Include
Develop and deliver appropriate global evidence generation strategies (preclinical studies, premarket studies, post market 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 the preclinical and clinical evidence generation strategies
Contribute and support the design of appropriate studies to meet premarket and post market needs
Design, plan and execute preclinical animal studies for the assessment of safety, performance, and effectiveness
Assess, communicate, and manage the risks associated to the preclinical evaluation of products, 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 and preclinical 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
A minimum of a bachelors degree in Biological Science or a related discipline is required. An advanced degree (masters or Ph.D.) is preferred.
Experience and Skills:
Required:
A minimum of 5 years of related scientific / technical experience within clinical and/or preclinical research is required.
Experience in clinical and/or preclinical science and processes along with an understanding of product development processes, related healthcare market environment, clinical trends, and/or preclinical or clinical trial regulations is required.
Proven track record of contributing to clinical and/or preclinical programs on time, within budget and in compliance to SOPs and regulations is required.
Preferred:
Experience working in Robotics is preferred.
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, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred.
Other:
This position will be located in Santa Clara, CA, or Cincinnati, OH and may require up to 25% domestic and international travel.
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.
Apply Now
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
US052 OH Cincinnati - 4545 Creek Rd, US328 CA Santa Clara - 5490 Great America Pkwy
Job Description:
Johnson & Johnson MedTech Surgery is recruiting for a Sr Scientific Clinical and Sr. Scientist Clinical and Preclinical Development, for Robotics & Digital Solutions, located in Santa Clara, California or Cincinnati, Ohio. This position has the unique opportunity to support Preclinical and Clinical activities within the Johnson & Johnson MedTech Surgery Robotics program.
Johnson & Johnsons 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.
Responsibilities Include
Develop and deliver appropriate global evidence generation strategies (preclinical studies, premarket studies, post market 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 the preclinical and clinical evidence generation strategies
Contribute and support the design of appropriate studies to meet premarket and post market needs
Design, plan and execute preclinical animal studies for the assessment of safety, performance, and effectiveness
Assess, communicate, and manage the risks associated to the preclinical evaluation of products, 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 and preclinical 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
A minimum of a bachelors degree in Biological Science or a related discipline is required. An advanced degree (masters or Ph.D.) is preferred.
Experience and Skills:
Required:
A minimum of 5 years of related scientific / technical experience within clinical and/or preclinical research is required.
Experience in clinical and/or preclinical science and processes along with an understanding of product development processes, related healthcare market environment, clinical trends, and/or preclinical or clinical trial regulations is required.
Proven track record of contributing to clinical and/or preclinical programs on time, within budget and in compliance to SOPs and regulations is required.
Preferred:
Experience working in Robotics is preferred.
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, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred.
Other:
This position will be located in Santa Clara, CA, or Cincinnati, OH and may require up to 25% domestic and international travel.
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.
Apply Now