Senior Clinical Scientist, Diagnostics & Regulatory Strategy

Beckman Coulter Diagnostics; Phoenix (AZ); Remote; USD 120,000 - 130,000; Full time

Benefits offered by this job

Remote work eligible

Bonus eligible

Job summary

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead global clinical trial strategies for the Neurodegenerative program, supporting US and EU markets. The role emphasizes regulatory compliance and milestone achievement for pivotal studies.

You will drive protocol development, liaise with regulators and external sites, and collaborate with R&D, Medical Affairs, and Quality to align clinical programs with product development and market access goals.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or related field with 9+ years of clinical research experience (US/EU trials).
• In-depth understanding of clinical study design and methodology for US/EU markets.
• Ability to review and interpret 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 for regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Act as scientific liaison with regulatory bodies, KOLs, and external sites.
• Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product development and access needs.
• Author and review clinical/regulatory documents to support clearance and commercialization.
• Build collaborations, mentor junior scientists, and stay updated on regulatory standards and diagnostic tech.

Skills

Clinical research

Regulatory submissions

Communication

Cross-functional collaboration

Education

Bachelor's in Life Sciences

Master's in Life Sciences

Doctoral degree

Job description

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead global clinical trial strategies for the Neurodegenerative program, supporting US and EU markets. The role emphasizes regulatory compliance and milestone achievement for pivotal studies.

You will drive protocol development, liaise with regulators and external sites, and collaborate with R&D, Medical Affairs, and Quality to align clinical programs with product development and market access goals.