Senior Clinical Scientist: Diagnostics Trials (Remote)

Beckman Coulter Diagnostics; Portland (OR); Remote; USD 120,000 - 130,000; Full time

Benefits offered by this job

Bonus eligibility

Remote work

Benefits package

Job summary

Beckman Coulter Diagnostics within the Danaher family is seeking a Principal Clinical Scientist to lead global clinical study design and regulatory strategies for US and EU markets. This remote-based role supports Beckman Coulter Diagnostics and Life Sciences, with onsite options in Chaska MN.

You will design studies, liaise with regulators, and align programs with product development. Strong leadership, communication, and cross-functional collaboration are essential.

Qualifications

• In-depth understanding of clinical study design and methodology in diagnostics, medical devices, or pharma.
• Excellent communication (written and verbal) and interpersonal skills for collaborating with cross-functional stakeholders.
• Ability to identify and solve complex issues in clinical trial conduct and scientific interpretation.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR) across multiple diagnostic modalities.
• Act as scientific and clinical liaison with regulatory bodies 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.
• Build internal and external collaborations, mentor junior scientists, and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Clinical study design

Regulatory liaison

Data interpretation

Written & verbal comms

Education

Bachelor’s degree in Life Sciences / Healthcare

Job description

Beckman Coulter Diagnostics within the Danaher family is seeking a Principal Clinical Scientist to lead global clinical study design and regulatory strategies for US and EU markets. This remote-based role supports Beckman Coulter Diagnostics and Life Sciences, with onsite options in Chaska MN.

You will design studies, liaise with regulators, and align programs with product development. Strong leadership, communication, and cross-functional collaboration are essential.