Principal Scientist, CDx IHC Development

Responsibilities

• Lead development of IHC-based CDx assays and kits from early feasibility through IVD readiness.
• Define assay design, platform selection, and development strategy aligned with CDx regulatory expectations.
• Oversee antibody selection, assay optimization, and standardization across platforms (e.g., Ventana, Dako, Leica).
• Guide development of scoring algorithms, cut-offs, and interpretation frameworks with pathology leadership.
• Lead analytical validation strategy and execution for CDx IHC assays, including sensitivity, specificity, precision, accuracy, and robustness.
• Ensure validation activities meet regulatory expectations and are conducted under design control.
• Oversee preparation and approval of validation protocols, reports, and technical documentation.
• Ensure traceability, risk management, and documentation in compliance with QSR 820 and ISO 13485.
• Provide oversight for implementation of CDx IHC assays in clinical trials and central laboratories.
• Ensure assay consistency, pathologist alignment, and scoring harmonization across sites.
• Support biomarker strategy, sample plans, and clinical cut-off justification.
• Partner with Regulatory Affairs and QA to support CDx regulatory strategy and submissions (e.g., IND/IDE, PMA/IVD).
• Ensure compliance with global regulatory requirements (FDA, NMPA, IVDR).
• Support bridging strategies from RUO/LDT to IVD CDx and contribute to regulatory interactions.
• Drive alignment with QMS, including design controls, change control, and audit readiness.
• Act as subject matter expert for CDx IHC development across internal and external stakeholders.
• Lead collaborations with CROs, central labs, and IVD partners.
• Mentor team members and contribute to building CDx development capabilities.

Final Word of Third Bullet Point

Automated System