Principal Clinical Scientist

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Principal Clinical Scientist responsible for clinical trial strategies within the US and EU regions for Beckman Coulter. This position reports to the Senior Manager, Clinical Science and is part of Beckman Coulter, Inc. Hematology and Urinalysis business unit located in Miami, FK and will be fully remote In this role, you will have the opportunity to: Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA 510(k)/PMA, CE IVDR) across multiple diagnostic modalities. Act as a scientific and clinical liaison with regulatory bodies, key opinion leaders, and external sites to develop protocols, claims, and evidence plans. Partner cross functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align clinical programs with product development and market access needs. Author and review clinical and regulatory documentation—including study reports, technical files, and publications—to support product clearance and commercialization. Build strong internal and external collaborations, mentor junior scientists, and maintain expertise in evolving regulatory standards, clinical guidelines, and diagnostic technologies. The essential requirements of the job include: Bachelor’s degree in Life Sciences, Healthcare, or a related filed with 9+ years of experience in clinical research, specifically with significant experience in US and/or EU trials, or a Master’s degree with 12+ years of experience or Doctoral degree with 4+ years of experience In-depth understanding of clinical study design and methodology in the diagnostics, medical device, or pharmaceutical industry with products intended for the US and EU markets Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation Ability to critically review and interpret scientific and clinical trial data, and oversee the scientific aspects of study protocols and reports Excellent communication (written and verbal) and interpersonal skills for collaborating with cross-functional stakeholders. Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel up to 10%, overnight, within US and/or EU Must have a valid driver’s license with an acceptable driving record It would be a plus if you also possess previous experience in: Experience in study designs for diagnostic technologies (IVD) is highly preferred, specifically for Hematology and Urinalysis Advanced degree in Science,