Principal Clinical Research Scientist (Life Sciences, Remote)

Job summary

This role involves leading and shaping the clinical evidence strategy for a diagnostic portfolio, focusing on global clinical studies that support the development and regulatory approval of medical products. The position requires strong scientific judgment and strategic thinking, with a blend of hands-on scientific contribution and leadership through collaboration.

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.
• Extensive 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 regulatory expectations.

Responsibilities

• Provide scientific leadership for the design and execution of global clinical studies, particularly in Blood Gas and Immunoassays.
• Act as a clinical science representative on New Product Development teams, contributing to clinical strategies and product lifecycle planning.
• Develop clinical study concepts and protocols, ensuring compliance with regulations.
• Author clinical study reports and support regulatory submissions and interactions.
• Review and interpret clinical data to support scientific conclusions.
• Collaborate with key investigators and support scientific publications and presentations.
• Represent the organization in scientific and regulatory forums as a clinical expert.

Skills

• Proficient in scientific writing and data interpretation.
• Excellent communication and collaboration skills, with the ability to influence stakeholders in a global environment.

Education

• Master’s or Doctoral degree in relevant fields.

Tools

• Familiarity with regulatory frameworks such as GCP, FDA, and IVDR.