Scientist/Senior Scientist, Companion Diagnostics (CDx) – IHC Development

Responsibilities

• Support implementation of IHC assays in clinical trials, including central laboratory qualification and oversight.
• Pathologist training and alignment, slide logistics, staining consistency, and scoring harmonization.
• Clinical trial sample strategy, feasibility studies, and biomarker cut-off justification.
• Regulatory & Quality Collaboration, including IDE/IND biomarker sections, CDx bridging strategies, and regulatory documentation.

Support preparation of regulatory documentation, including IDE/IND biomarker sections, CDx bridging strategies (RUO/LDT → IVD), and analytical and clinical performance summaries.

Ensure assay development aligns with QMS requirements, design controls, and document traceability.

Collaborate with clinical teams on sample strategy, feasibility studies, and biomarker cut-off justification.

Work closely with Regulatory Affairs and Quality Assurance to ensure compliance with FDA CDx guidance (US), NMPA/CDE requirements (China), and IVDR (EU).

Prepare regulatory documentation, including IDE/IND biomarker sections, CDx bridging strategies (RUO/LDT → IVD), and analytical and clinical performance summaries.

Part 1 I confirm that my application responses are my own work and were not generated by any AI tool. Part 2 Support Part 3 This application is being completed by an automated system.