Senior Clinical Scientist, Neurodegenerative Diagnostics

Beckman Coulter Diagnostics; San Jose (CA); On-site; USD 120,000 - 130,000; Full time

Benefits offered by this job

Bonus eligibility

Remote work eligible

Comprehensive benefits

Job summary

Beckman Coulter Diagnostics seeks a Principal Clinical Scientist to lead clinical trial strategies for the US and EU in the Neurodegenerative program. This remote role supports Beckman Coulter Diagnostics and Life Sciences, driving study designs and regulatory submissions.

You will collaborate with regulatory bodies, manage evidence plans, and mentor junior scientists while advancing diagnostic technologies and guidelines across markets.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or related field with 9+ years of clinical research experience or Master’s with 12+ years or Doctoral with 4+ years.
• Deep understanding of clinical study design and methodology for US/EU markets in diagnostics, medical devices, or pharma.
• Excellent written and verbal communication and ability to work with cross-functional stakeholders.

Responsibilities

• Design clinical studies and evidence strategies for global regulatory submissions (FDA 510(k)/PMA, CE‑IVDR).
• Act as scientific and clinical liaison with regulators, KOLs, and external sites to develop protocols and evidence plans.
• Collaborate with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align programs with product development and market access.
• Author and review clinical and regulatory documents—study reports, technical files, publications.
• Mentor junior scientists and maintain up-to-date knowledge of regulatory standards and diagnostic technologies.

Skills

Clinical research

Regulatory understanding

Communication skills

Cross-functional collaboration

Study design expertise

Education

Bachelor's degree in Life Sciences/Healthcare

Master's or Doctoral degree (advantageous)

Job description

Beckman Coulter Diagnostics seeks a Principal Clinical Scientist to lead clinical trial strategies for the US and EU in the Neurodegenerative program. This remote role supports Beckman Coulter Diagnostics and Life Sciences, driving study designs and regulatory submissions.

You will collaborate with regulatory bodies, manage evidence plans, and mentor junior scientists while advancing diagnostic technologies and guidelines across markets.