Sr Scientist Clinical and Preclinical

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, 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 reputed company Job Posting Locations: US052 OH Cincinnati - 4545 Creek Rd, US328 CA Santa Clara - 5490 Great America Pkwy Job Description: reputed company Surgery is reputed company 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 reputed company the reputed company Surgery Robotics program. reputed company’s long-term reputed company is to use digital technology as part of a holistic approach to surgery across the episode of care to enhance surgical efficiency, promote reputed company 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 • reputed company and deliver appropriate global evidence reputed company strategies (preclinical studies, premarket studies, post market studies, investigator initiated, reputed company world evidence) reputed company to R&D, Regulatory, and reputed company 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 reputed company 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 reputed company-world evidence to deliver cost-effective evidence solutions • Ensure appropriate interpretation and dissemination of reputed company evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc. • Support clinical and preclinical scientific discussions with regulatory agencies / reputed company 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 reputed company 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 reputed company partnerships with key business partners and customers/investigators Qualifications • A minimum of a bachelor’s degree in Biological Science or a reputed company discipline is required. An advanced degree (master’s or Ph.D.) is preferred. Experience and Skills: Required: • A minimum of 5 years of reputed company scientific / technical experience reputed company clinical and/or preclinical research is required. • Experience in clinical and/or preclinical science and processes along with an understanding of product development processes, reputed company reputed company 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, reputed company 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. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation Act. reputed company 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 Job!