Principal Clinical Research Scientist

Job summary

The Principal Clinical Research Scientist is responsible for leading the clinical evidence strategy for a diagnostic portfolio, focusing on the design and execution of global clinical studies. This role combines scientific leadership with collaboration across functions and external stakeholders, contributing to the development and regulatory approval of new medical products.

Qualifications

• Master’s degree in Life Sciences, Healthcare, or a related field with 7+ years of clinical research experience, or a Doctoral degree with 5+ years of experience.
• Strong experience in clinical evidence generation for EU and/or US markets, particularly in diagnostics, medical devices, or pharmaceutical development.
• Solid understanding of clinical study design, execution, and interpretation, including regulatory expectations.
• Experience with FDA regulatory interactions and negotiations related to clinical evidence.
• Proven ability to solve complex scientific challenges and translate clinical data into meaningful insights.
• High proficiency in scientific writing and critical data review.
• Excellent communication and collaboration skills, capable of influencing stakeholders in a global matrix organization.

Responsibilities

• Provide scientific and strategic leadership for multiple global clinical studies in Blood Gas and Immunoassays.
• Act as the clinical science representative on New Product Development and Core Teams.
• Lead the development of clinical study concepts and protocols, ensuring compliance with regulations.
• Author clinical study reports and support regulatory submissions.
• Review and synthesize clinical data to support scientific conclusions.
• Establish collaborations with key investigators and support scientific publications.
• Represent the organization in scientific, clinical, and regulatory forums.

Skills

• Strong analytical and problem-solving skills.
• Proficient in scientific writing and data interpretation.
• Effective communication and collaboration abilities.

Education

• Master’s degree or Doctoral degree in relevant fields.

Tools

• Familiarity with GCP, FDA, IVDR regulations.