Senior Clinical Scientist - Neurodegenerative Trials (Remote)

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

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