Senior Clinical Scientist - Diagnostics Trials (Remote)

Beckman Coulter Diagnostics; Houston (TX); Remote; USD 120,000 - 130,000; Full time

Benefits offered by this job

Remote work option

Medical/dental/vision insurance

401(k) plan

Job summary

Beckman Coulter Diagnostics, part of Danaher Diagnostics, seeks a Principal Clinical Scientist to lead global clinical study designs and regulatory strategies for US/EU markets. You will drive evidence plans and collaborate with R&D, Regulatory, Medical Affairs, and Quality to ensure compliant submissions.

The role is remote-based with onsite option in Chaska, MN, offering bonus eligibility and a strong benefits package.

Qualifications

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

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA/CE) across diagnostic modalities.
• Act as scientific liaison with regulatory bodies, KOLs, and external sites to develop protocols and evidence plans.
• Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product development and market access.
• Author and review clinical/regulatory documents including study reports and publications.
• Mentor junior scientists and maintain expertise in evolving regulatory standards and diagnostic tech.

Skills

Clinical trial design

Regulatory affairs knowledge

Cross-functional collaboration

Scientific writing

Regulatory liaison

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree in Science/Regulatory/Clinical Affairs

Clinical Research Certification (SoCRA/ACRP)

Job description

Beckman Coulter Diagnostics, part of Danaher Diagnostics, seeks a Principal Clinical Scientist to lead global clinical study designs and regulatory strategies for US/EU markets. You will drive evidence plans and collaborate with R&D, Regulatory, Medical Affairs, and Quality to ensure compliant submissions.

The role is remote-based with onsite option in Chaska, MN, offering bonus eligibility and a strong benefits package.