Senior Preclinical Research Scientist

Professional Life Sciences Recruiter at Medasource

Senior Scientist - Preclinical Research

Duration: 1 year contract with probability of extensions

Our clients 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.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

• Leads and supports product evaluations involving animate, inanimate, and cadaveric models
• Performs research supporting development of products or procedures in minimally invasive robotic surgery
• Assisting or conducting investigations for medical device development and preclinical evidence generation aligned to R&D, Regulatory, and Commercial needs
• Coordinate and ensure accurate documentation of laboratory activities
• Conduct lab activities in compliance with USDA, AAALAC, and J&J Animal use policies
• Ensure compliance with 21 CFR Part 58 – Good Laboratory Practices
• 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
• Act as study coordinator in support of the Study Director
• Act as Study Director projects of varying levels of complexity
• Assess, communicate, and manage the risks associated to the preclinical evaluation of products.
• Assist in appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.
• Demonstrate the ability to 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

• A minimum of a bachelor’s degree in Biological Science or a related discipline is required.

• A minimum of 5 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, clinical trends, and preclinical regulations is required.
• 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 studies
• Understanding of good documentation practices
• Familiarity with animal welfare regulations and IACUC

• Experience working in Medical Devices or Robotics is preferred
• Experience working with large animal models is desired
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred.