Principal Clinical Scientist (Neurodegenerative)

Beckman Coulter Diagnostics; Boston (MA); Hybrid; USD 120,000 - 130,000; Full time

Benefits offered by this job

Remote work eligibility

Benefits package

Job summary

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions, supporting regulatory submissions across multiple diagnostic modalities. The role requires driving study designs, ensuring regulatory compliance, and guiding milestones in key markets.

This position is remote-based with possible onsite in Chaska, MN, offering flexible arrangements and strong collaboration with R&D, Regulatory, and Medical Affairs to advance diagnostic

Qualifications

• Excellent communication and interpersonal skills for cross-functional work.
• Strong understanding of clinical study design and regulatory requirements.
• Ability to critically review trial data and oversee study protocols and reports.
• Experience liaising with regulatory bodies and external sites.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Act as scientific/regulatory liaison with regulators, KOLs, and external sites.
• Collaborate with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs.
• Author and review clinical/regulatory documentation including study reports and technical files.
• Mentor junior scientists and maintain expertise on evolving regulatory standards.

Skills

Excellent communication

Regulatory understanding

Cross-functional collaboration

Scientific interpretation

Interpersonal skills

Job description

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

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.

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.

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 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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

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