Principal Clinical Research Scientist (Life Sciences, Remote)

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 senior role requires strong scientific judgment and strategic thinking to influence various stakeholders and ensure compliance with regulatory standards.

Qualifications

• Master’s degree in Life Sciences, Healthcare, or 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 or medical devices.
• Strong understanding of clinical study design, execution, and regulatory expectations.

Responsibilities

• Provide scientific leadership for the design and execution of global clinical studies, including 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 GCP, FDA, and IVDR 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

• Proficiency in scientific writing and critical data review.
• Excellent communication and collaboration skills, with the ability to influence stakeholders in a global organization.

Education

• Master’s or Doctoral degree in relevant fields.

Tools

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