Senior Scientist, Precision Medicine - Contractor

Role Summary

Senior Scientist, Precision Medicine (Contractor) will join the Precision Medicine team to advance biomarker and companion diagnostic (CDx) testing programs across our oncology pipeline. This contractor role will manage the operational and scientific aspects of diagnostic development, including assay validation, vendor oversight, regulatory preparation, and clinical trial integration. The candidate will have experience in diagnostic assay development, biomarker operations, and regulatory submissions and will thrive in a collaborative, fast-paced biotech environment.

Responsibilities

• Lead the execution of Companion Diagnostic (CDx) programs in alignment with drug development timelines.
• Drive operational readiness for global diagnostic development including U.S., EU IVDR, and Japan PMDA pathways.
• Maintain diagnostic vendor oversight for CDx development, central biomarker testing for patient enrollment, and ctDNA analysis.
• Author biomarker and diagnostic sections of clinical trial protocols, ICFs, and biomarker management plans, aligning diagnostic implementation with precision medicine strategy.
• Collaborate cross-functionally with Clinical Development, Regulatory, and Clinical Operations, external partners to align biomarker/CDx strategy to global registration pathways (FDA, IVDR, PMDA).

Qualifications

• Ph.D. (or MS with equivalent experience) in Molecular Biology, Pathology, Genomics, Biomedical Sciences, or related field.
• PhD with 5+ years of industry experience or MS with 8+ years with biomarker testing and diagnostic development in pharma/biotech setting, preferably in oncology or Precision medicine.
• Strong understanding of IVD/CDx development lifecycle, including analytical and clinical validation and regulatory frameworks (FDA, IVDR, PMDA).
• Hands-on or oversight experience with NGS-based assays, ctDNA testing, IHC, or other molecular diagnostic platforms.
• Experience in clinical trial documentation authoring, sample management logistics, and diagnostic lab operations.
• Proven ability to work cross-functionally in a fast-paced, collaborative biotech environment.
• Strong written and verbal communication skills; ability to clearly interpret and present complex scientific and operational data.

Skills

• NGS, PCR, ctDNA, MRD detection, and emerging diagnostic platforms.
• Data analysis and bioinformatics collaboration.
• Cross-functional collaboration and program management.
• Regulatory compliance (FDA CDx, IVDR, CLIA, GCP, CAP).
• Clear written and verbal communication.

Education

• Ph.D. (or MS with equivalent experience) in Molecular Biology, Pathology, Genomics, Biomedical Sciences, or related field.