Principal Clinical Scientist

Danaher•Miami, FL

1d•Remote

About The Position

The Principal Clinical Scientist is 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. You will act as a scientific and clinical liaison with regulatory bodies, key opinion leaders, and external sites to develop protocols, claims, and evidence plans. You will partner cross functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align clinical programs with product development and market access needs. You will also author and review clinical and regulatory documentation—including study reports, technical files, and publications—to support product clearance and commercialization. Additionally, you will build strong internal and external collaborations, mentor junior scientists, and maintain expertise in evolving regulatory standards, clinical guidelines, and diagnostic technologies.

Requirements

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.
Ability to travel up to 10%, overnight, within US and/or EU
Must have a valid driver’s license with an acceptable driving record

Nice To Haves

Experience in study designs for diagnostic technologies (IVD) is highly preferred, specifically for Hematology and Urinalysis
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.