Principal Clinical Scientist

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 worlds 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.

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Principal Clinical Scientist. 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 remote based (can also be onsite in Chaska MN). At Danaher Diagnostics our vision is to be the leading provider of seamlessly connected diagnostic solutions.

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 CEIVDR) 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 crossfunctionally 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 documentationincluding study reports technical files and publicationsto 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:

• Bachelors 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 Masters 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.

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 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).

Danaher Diagnostics a Danaher company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at .

This job is also eligible for bonus/incentive pay.

WithinDanaherDiagnosticswe believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that workingwithinDanaherDiagnosticscan provide.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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