Clinical Affairs Scientist
Core
Support clinical evidence generation, study design, and regulatory submissions for companion diagnostics in oncology.
Role type
Senior IC clinical affairs scientist (oncology diagnostics)
Builds
Companion diagnostics for oncology
Domain
Medical diagnostics / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and oversight, biostatistics, medical writing, regulatory standards interpretation, database design (EDC/CRF), risk analysis, data monitoring
Preferred skills
IVD product development, Good Clinical Practice (GCP), oncology/immunology/pathology knowledge, FDA interaction experience
Technologies
EDC systems, case report forms
Responsibilities
Design study protocols and reports, develop EDC systems and CRFs, ensure statistical validity of results, collaborate on regulatory submissions and IFU, oversee clinical marketing materials, maintain SOPs, author manuscripts and presentations, support audits/inspections
Seniority
Senior, hands-on IC