Job Description
Confidential oncology biotech seeking a Fractional Regulatory CDx Strategy Advisor to help shape diagnostic strategy alongside an innovative drug development programme that they have.
You'll provide expert guidance on:
Companion diagnostic (CDx) strategy
FDA pathways (PMA, Q-Sub, IDE, 510(k))
EU IVDR regulatory strategy
Oncology biomarkers and translational medicine
Molecular diagnostics, liquid biopsy and IHC assays
Global regulatory approval pathways for precision medicine products
We're looking for someone with proven CDx experience in a start-up environment. Someone who has experience taking a Companion diagnostic through the stages of approval, strong US and EU regulatory knowledge.
Flexible consultancy engagement with significant strategic influence reporting directly into the co-founder.
You'll provide expert guidance on:
Companion diagnostic (CDx) strategy
FDA pathways (PMA, Q-Sub, IDE, 510(k))
EU IVDR regulatory strategy
Oncology biomarkers and translational medicine
Molecular diagnostics, liquid biopsy and IHC assays
Global regulatory approval pathways for precision medicine products
We're looking for someone with proven CDx experience in a start-up environment. Someone who has experience taking a Companion diagnostic through the stages of approval, strong US and EU regulatory knowledge.
Flexible consultancy engagement with significant strategic influence reporting directly into the co-founder.
Ready to Apply?
Submit your application today and join our talented team at Hays Life Sciences.
Submit ApplicationJob Details
- Location City of London, City and County of the City of London
- Job Type Full-time
- Category other-general
- Posted Date July 08, 2026
- Application Deadline August 17, 2026