BioFire Diagnostics, LLC. is seeking a Clinical Research Scientist to join the Clinical Affairs department. The scientist will manage Clinical Research Associates while leading clinical evaluations of molecular IVD tests on BioFire's FilmArray system (see www.filmarray.com). The Clinical Research Scientist is responsible for designing and executing clinical evaluations of diagnostic products and writing study reports for regulatory submission. Applicants should address any prior experience with human subjects research as well as their interest in IVDs in a well-written cover letter to accompany their application.
This position requires a PhD in molecular biology, microbiology or equivalent. Postdoctoral experience is highly desired. Must have demonstrated ability to write clear and concise scientific reports. Must have strong organizational and communication skills. The ability and desire to work in a team and interact with scientists and managers from other teams and external study sites, as well as the ability to prioritize and work to deadlines in a fast-paced environment are necessary. Preferred experience with the development and implementation of molecular diagnostic assays and human subjects research including GCP. Experience managing and mentoring others, and knowledge of clinical laboratory microbiology/testing and/or proficiency with data management and data analysis programs are also preferred. Requires up to 30% travel.
Internal Number: 913
About BioFire Diagnostics LLC.
With FDA clearance of the revolutionary FilmArray system, BioFire has set a new standard in molecular diagnostics. Featuring unmatched usability, the FilmArray’s comprehensive respiratory panel tests for 20 viral and bacterial targets in one, 60-minute test. That’s a feat that no other product on the market can match. Physicians attain answers sooner. Laboratories maximize productivity and reduce costs.
Innovation at BioFire continues with the development of new panels like the Blood Culture Identification Panel, Gastrointestinal Panel, Meningitis Panel and the Lower Respiratory Panel. Much like the FDA cleared Respiratory Panel, these new additions will provide fast, comprehensive results.