Principal Clinical Scientist

Danaher•Chaska, MN

4d•Hybrid

About The Position

At Danaher Diagnostics, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Danaher Diagnostics is a community of six companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. This role is responsible for clinical trial strategies within the US and EU regions for Danaher Diagnostics. This role will specifically support Beckman Coulter Diagnostics and Life Sciences, operating companies of Danaher Diagnostics. You will drive strategic study designs, ensuring regulatory compliance, and achieving key milestones for critical clinical studies in these vital markets. This position is part of the Danaher Diagnostics, Beckman Coulter Inc. organization and will be located on-site at either Chaska, MN or Miami, FL. At Danaher Diagnostics, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

Requirements

Bachelor’s degree in Life Sciences, Healthcare, or a related field 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 same 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.

Nice To Haves

Experience in study designs for diagnostic technologies (IVD) is highly preferred, specifically for Clinical Chemistry, Immunoassays, Hematology, Urinalysis, Flow Cytometry, and/or Biomarkers.
Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
Professional certification in Clinical Research (e.g., SoCRA, ACRP).

Responsibilities

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.