Principal Scientist, Clinical Biomarkers
Core
Design, execute, and interpret biomarker activities across clinical studies to inform clinical development, regulatory submissions, and program decisions for solid organ transplants.
Role type
Principal Scientist, Clinical Biomarkers
Builds
Clinical trial data and regulatory documentation supporting solid organ transplant therapies
Domain
Biotechnology / Clinical Development / Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PhD in immunology/molecular/cellular biology/translational sciences, 5+ years industry experience in biomarker strategy, assay validation principles, clinical sample workflows, regulatory document authoring, cross-functional collaboration, independent problem-solving
Preferred skills
B cell immunology experience, nephrology program experience, solid organ transplant program experience, regulatory filing support
Technologies
Biomarker assays, clinical sample collection and analysis workflows
Responsibilities
Develop and implement comprehensive biomarker strategy for clinical studies, drive analysis and interpretation of biomarker data to generate mechanistic insights, author and review biomarker sections for protocols and regulatory documents, identify fit-for-purpose biomarker assays, collaborate on vendor selection and technology transfer of assays, oversee outsourced projects with CROs and technology partners
Seniority
Principal, hands-on IC with strategic oversight
