Senior Clinical Scientist – Remote Diagnostics Strategy

Beckman Coulter Diagnostics; Miami (FL); Remote; USD 120,000 - 130,000; Full time

Benefits offered by this job

Bonus eligibility

Benefits package

Remote-friendly

Job summary

Beckman Coulter Diagnostics, part of Danaher Diagnostics, seeks a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions. You will drive designs, ensure regulatory compliance, and guide milestones for pivotal studies across diagnostic modalities.

The role is remote-based with potential onsite in Chaska, MN. Strong expertise in regulatory submissions and collaboration with cross‑functional teams is essential.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 9+ years of experience in clinical research; Master’s with 12+ years; Doctoral with 4+ years.

Responsibilities

• Design clinical studies and evidence strategies for global regulatory submissions (FDA 510(k)/PMA, CE-IVDR).
• 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 clinical programs with product development and market access needs.
• Author and review clinical/regulatory documentation including study reports, technical files, and publications.
• Mentor junior scientists and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Clinical study design

Regulatory strategy

Study protocols

Regulatory submissions

Scientific communication

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree

Doctoral degree

Job description

Beckman Coulter Diagnostics, part of Danaher Diagnostics, seeks a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions. You will drive designs, ensure regulatory compliance, and guide milestones for pivotal studies across diagnostic modalities.

The role is remote-based with potential onsite in Chaska, MN. Strong expertise in regulatory submissions and collaboration with cross‑functional teams is essential.