Principal Clinical Scientist (Diagnostics)

Location: Remote from the United States, with an onsite option in Chaska, Minnesota

Annual salary: $120,000–$165,000, plus bonus or incentive pay

Company

hirify.global Diagnostics develops diagnostic tools and connected diagnostic solutions through a community of six operating companies, including Beckman Coulter Diagnostics and Life Sciences.

What you will do

• Design clinical studies and evidence strategies for global regulatory submissions, including FDA 510(k)/PMA and CE-IVDR.
• Serve as a scientific and clinical liaison for regulatory bodies, key opinion leaders, and external research sites.
• Develop study protocols, product claims, and evidence plans for diagnostic technologies.
• Partner with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align clinical programs with product development and market access.
• 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 regulatory standards and clinical guidelines.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 9+ years of relevant clinical research experience; alternatively, a Master’s degree with 12+ years or a doctoral degree with 4+ years.
• Significant experience with clinical research and trials in the United States and/or European Union.
• In-depth knowledge of clinical study design and methodology in diagnostics, medical devices, or pharmaceuticals.
• Ability to identify and solve complex issues in clinical trial conduct and scientific interpretation.
• Ability to critically review clinical and scientific data and oversee study protocols and reports.
• Excellent written, verbal, and interpersonal communication skills.

Nice to have

• Experience designing studies for IVD technologies, particularly Clinical Chemistry, Immunoassays, Hematology, Urinalysis, Flow Cytometry, or Biomarkers.
• Advanced degree in Science, Healthcare, Regulatory Affairs, or Clinical Affairs.
• Professional clinical research certification such as SoCRA or ACRP.

Culture & Benefits

• Flexible remote work arrangement for eligible roles.
• Paid time off and medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Bonus or incentive pay eligibility.
• Career growth and development opportunities in a global diagnostics organization.