Principal Clinical Scientist (Neurodegenerative)

Beckman Coulter Diagnostics; Denver (CO); On-site; USD 120,000 - 130,000; Full time

Job summary

Beckman Coulter Diagnostics, part of Danaher Diagnostics, is seeking a Principal Clinical Scientist to lead clinical trial strategies in the US and EU for the Neurodegenerative program. You will drive study designs, ensure regulatory compliance, and achieve milestones for pivotal trials in these markets.

This role can be remote or onsite in Chaska, MN. You will collaborate with Regulatory, R&D, Medical Affairs, Quality, and Commercial teams, mentor junior scientists, and contribute to product

Qualifications

• Bachelor’s degree in Life Sciences with 9+ years in clinical research (US/EU trials).
• Proven ability to design and interpret clinical studies for diagnostic/medical device contexts.
• Experience interacting with regulatory bodies and preparing regulatory submissions.
• Strong written and verbal communication for cross‑functional teams.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Serve as scientific liaison with regulators, key opinion leaders, and external sites.
• Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product needs.
• Author and review clinical and regulatory documents to support clearance and commercialization.
• Mentor junior scientists and stay current with evolving regulatory standards and technologies.

Skills

Clinical trial design

Regulatory understanding

Cross-functional collaboration

Scientific communication

Mentoring

Education

Bachelor’s degree in Life Sciences

Master’s or Doctoral degree in related field

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives.

Learn about the Danaher Business System which makes everything possible.

Principal Clinical Scientist

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 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, 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.

At Beckman Coulter Diagnostics we 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 working for Beckman Coulter Diagnostics can provide.

The annual salary range for this role is $120K-$130K.

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.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].