Clinical Affairs Scientist

Job Summary

To support clinical evidence generation in the medical diagnostic field, the full-time Clinical Affairs Scientist will collaborate with cross-functional teams on companion diagnostics in oncology, focusing on clinical trial designs, regulatory applications, and scientific marketing deliverables while having the option to work remotely.

Key responsibilities

• Provide thought leadership on clinical topics to support strategy development and execution
• Generate content for external validation studies, including study design and authoring study protocols and reports
• Collaborate with regulatory and development teams during the submission process, including authoring clinical performance documentation

Required qualifications

• Master's degree or advanced degree in pharmaceutical, medical, or relevant biomedical science fields
• 4+ years of experience in IVD product development, clinical research, medical writing, or clinical science
• Familiarity with clinical trial design, conduct, and oversight, including biostatistics and Good Clinical Practice
• Experience working with external partners and/or regulatory bodies, including the FDA
• Knowledge in oncology, immunology, and/or pathology preferred