Senior Clinical Scientist – Diagnostics Trials & Regulatory

Beckman Coulter Diagnostics; Milwaukee (WI); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Bonus eligibility

Remote work option

Benefits package

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 regions. This remote/onsite role focuses on regulatory submissions, study design, and evidence plans across multiple diagnostic modalities.

The position emphasizes collaboration with R&D, Regulatory, and Medical Affairs, along with mentoring junior scientists and staying current on regulatory standards.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or related field with 9+ years of experience in clinical research, or a Master’s degree with 12+ years, or Doctoral degree with 4+ years of experience.
• In-depth understanding of clinical study design and methodology in diagnostics, medical device, or pharmaceutical industry with US/EU market products.
• Proven ability to identify and resolve complex issues in clinical trial conduct and scientific interpretation.
• Ability to critically review and interpret scientific and clinical trial data and oversee study protocols and reports.
• Excellent communication and interpersonal skills for cross-functional collaboration.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR) across diagnostic modalities.
• Serve as scientific/clinical liaison with regulatory bodies, key opinion leaders, and external sites to develop protocols, claims, and evidence plans.
• Partner 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.
• Mentor junior scientists and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Clinical study design

Regulatory submissions

Regulatory liaison

Cross-functional collaboration

Scientific writing

Mentoring

US/EU trial experience

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree in related field

Doctoral degree in related field

Job description

Beckman Coulter Diagnostics, part of Danaher Diagnostics, is seeking a Principal Clinical Scientist to lead clinical trial strategies in the US and EU regions. This remote/onsite role focuses on regulatory submissions, study design, and evidence plans across multiple diagnostic modalities.

The position emphasizes collaboration with R&D, Regulatory, and Medical Affairs, along with mentoring junior scientists and staying current on regulatory standards.