Clinical Study Lead - Precision Medicine

Clinical Study Lead, Precision Medicine

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2 positions | New role within MDx CRO's Precision Medicine team

About the role

MDx CRO is creating  two new Clinical Study Lead positions   within our Precision Medicine Clinical Alliances team.
This is  not a conventional CRA role  . It is not a purely regulatory role either.
It sits where  biomarker science, investigational IVDs, clinical operations and drug development meet  .
You will lead the IVD and biomarker study workstream within complex drug development programmes, translating regulatory strategy into country activation, testing site and clinical site execution, and high-quality study delivery.
You will need to move confidently between  Competent Authorities, Ethics Committees, pharmaceutical sponsors, diagnostic partners, CRO teams, testing laboratories and clinical sites  . You will understand not only how to obtain study approval, but also how the diagnostic component must operate inside a clinical trial so that the resulting evidence remains robust and usable.
The role is international, client-facing and hands-on.  International travel may be required   for testing-site activities, monitoring, clinical sites, client meetings and other study activities.

What you will own

Lead the IVD performance-study workstream   within combined clinical trials and other biomarker-driven drug development programmes.
Lead submission strategy and execution to National Competent Authorities and Ethics Committees  , including initial applications or notifications, country adaptations, requests for information, amendments, substantial modifications and ongoing authority or committee correspondence.
Coordinate the preparation and review of country submission packages, including  CPSPs, relevant protocol content, informed consent language, site suitability documentation, national forms and other study-specific materials  .
Drive country start-up and activation readiness, ensuring applicable regulatory and Ethics Committee conditions are understood, tracked and resolved.
Plan and conduct IVD study monitoring and testing-site or laboratory oversight   in line with GCP, IVDR, ISO 20916, applicable study documents and MDx quality procedures.
Review execution where diagnostic evidence is actually generated, including sample and testing workflows, protocol compliance, traceability, study documentation, deviations, data quality and corrective actions as applicable.
Identify and escalate issues that could affect  study integrity, diagnostic evidence, country activation, downstream regulatory strategy or the therapeutic development programme  .
Coordinate across pharmaceutical sponsors, diagnostic manufacturers, CRO and clinical-trial teams, central or local laboratories, clinical sites, local representatives and country specialists.
Maintain clear multi-country trackers, submission records, timelines, study files, decisions and client communications.
Apply knowledge of  global regulatory frameworks for biomarker-based drug development  , including the EU IVDR and clinical-trial interface, FDA investigational IVD, IDE and companion-diagnostic considerations, and country-specific authority and ethics requirements.
Contribute to client meetings, regulatory intelligence and the continued development of MDx country knowledge and Precision Medicine delivery methods.

Who we are looking for

You should bring a degree in life sciences, biomedical sciences, molecular biology, pharmacy, clinical research or a related discipline, together with demonstrable hands-on experience in clinical or performance-study delivery.
We are particularly interested in…