Principal Clinical Scientist

About the role

This role offers the opportunity to shape clinical strategies that support the development and commercialization of innovative diagnostic solutions. You will lead complex clinical study programs across US and EU markets, ensuring scientific rigor, regulatory alignment, and successful execution. The position combines scientific expertise, strategic thinking, and cross-functional collaboration to advance healthcare technologies with measurable patient impact. You will work closely with regulatory, medical, quality, research, and commercial teams to create evidence strategies that support global product adoption. This is an influential role for a clinical science leader passionate about diagnostics, innovation, and improving healthcare outcomes. You will contribute to a collaborative environment where scientific excellence, continuous learning, and impactful solutions are prioritized.

Accountabilities

As a Principal Clinical Scientist, you will lead clinical trial strategies and evidence-generation initiatives supporting diagnostic product development and regulatory submissions. You will serve as a scientific expert, guiding study design, interpreting clinical data, and collaborating with internal and external stakeholders to ensure successful clinical programs.

• Develop and execute clinical study strategies supporting global regulatory submissions, including FDA and CE-IVDR pathways.
• Design clinical studies and evidence plans across multiple diagnostic technologies and product portfolios.
• Act as a scientific and clinical partner to regulatory agencies, key opinion leaders, external study sites, and internal teams.
• Create and review clinical documentation, including study protocols, reports, technical documentation, and scientific publications.
• Partner with R&D, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams to align clinical programs with business and market access objectives.
• Provide scientific oversight throughout clinical study execution, ensuring compliance with applicable standards and regulations.
• Analyze and interpret clinical and scientific data to support decision-making and product development strategies.
• Identify and resolve complex clinical trial challenges through strong scientific judgment and problem-solving skills.
• Build collaborative relationships with internal and external stakeholders while mentoring junior scientists.
• Maintain expertise in evolving diagnostic technologies, regulatory requirements, and clinical research best practices.

Requirements

The ideal candidate is an experienced clinical research professional with strong expertise in diagnostics, medical devices, or related healthcare technologies. You should have a proven ability to design clinical studies, interpret scientific data, and influence cross-functional teams in a regulated environment.

• Bachelor's degree in Life Sciences, Healthcare, or a related discipline with 9+ years of relevant clinical research experience, including significant US and/or EU trial experience.
• Master's degree with 12+ years of relevant experience, or Doctoral degree with 4+ years of relevant experience.
• Strong knowledge of clinical study design and methodology within the diagnostics, medical device, or pharmaceutical industries.
• Experience supporting products intended for US and European markets.
• Ability to critically evaluate scientific and clinical trial data and oversee study protocols and reports.
• Strong problem-solving skills with the ability to address complex clinical and scientific challenges.
• Excellent written and verbal communication skills with the ability to collaborate across diverse stakeholder groups.
• Experience with in vitro diagnostic (IVD) technologies is highly preferred, particularly in areas such as Clinical Chemistry, Immunoassays, Hematology, Urinalysis, Flow Cytometry, or Biomarkers.
• Advanced degree in Science, Healthcare, Regulatory Affairs, or Clinical Affairs is a plus.
• Professional certification in Clinical Research (such as SoCRA or ACRP) is preferred.

Benefits

• Competitive annual salary range of $120,000-$165,000 USD.
• Eligibility for bonus and incentive compensation programs.
• Flexible work arrangements, including remote work eligibility for this role.
• Comprehensive healthcare coverage, including medical, dental, and vision insurance.
• 401(k) retirement plan.
• Paid time off and employee leave programs.
• Benefits programs designed to support overall health, wellbeing, and work-life balance.
• Opportunities for professional growth, development, and career advancement.
• Access to a collaborative environment focused on innovation and meaningful healthcare impact.