Confidential oncology biotech seeking a Fractional Regulatory CDx Strategy Advisor to help shape the diagnostic strategy alongside a precision medicine oncology programme.

This is a highly strategic role, working directly with the co-founder and senior leadership team. The focus is not on submission execution, but on defining the regulatory pathway and evidence strategy needed to successfully develop and commercialise a companion diagnostic alongside the therapeutic asset.
Key areas of expertise:

Companion diagnostic (CDx) development and approval strategy
US regulatory pathways including PMA, Q-Sub, IDE and 510(k)
EU IVDR strategy and implementation
Biomarker development and diagnostic evidence generation
Precision medicine and targeted oncology therapies
Molecular diagnostics, liquid biopsy and IHC-based assays
Regulatory strategy across drug-diagnostic co-development programmes
We're looking for someone who has been through this before and under...