Principal Clinical Scientist (On-Site US). This role is responsible for clinical trial strategies within the US and EU regions for Danaher Diagnostics Neurodegenerative program. 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 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, 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 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.
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 Neurodegenerative 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 it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
This job is also eligible for bonus/incentive pay.
The annual salary range for this role is $120K-$130K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
