Principal Clinical Scientist

At Danaher Diagnostics, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us every day as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our team is involved in every stage of diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes globally.

About the role

This role is responsible for clinical trial strategies within the US and EU regions for Danaher Diagnostics, specifically supporting Beckman Coulter Diagnostics and Life Sciences. You will drive strategic study designs, ensure regulatory compliance, and achieve key milestones for critical clinical studies. This position is part of Danaher Diagnostics, Beckman Coulter Inc. and can be remote or onsite in Chaska, MN.

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.

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 a 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.

Qualifications (Preferred)

• Experience in study designs for diagnostic technologies (IVD), 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).

Benefits

• Comprehensive health care programs, including medical, dental, and vision insurance.
• Paid time off.
• 401(k) retirement plan.
• Bonus/incentive pay eligibility.

Pay

The annual salary range for this role is $120,000–$165,000. This range may be modified in the future and is eligible for bonus/incentive pay.

Schedule

This position is eligible for a remote work arrangement, allowing you to work remotely from your home. Additional details about this arrangement will be provided during the interview process.