Descripción de la oferta
Clinical Study Lead, Precision Medicine2 positions | New role within MDx CRO's Precision Medicine team About the roleMDx 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 ownLead 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 forYou 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 candidates who combine NCA and Ethics Committee/IRB submission experience with clinical monitoring or study-management experience . You should be comfortable working with IVDs, molecular diagnostics, clinical-trial assays, biomarkers or companion diagnostics, and understand how diagnostic testing can influence patient selection and therapeutic development. Working knowledge of GCP is expected. Experience with IVDR performance studies and ISO 20916 would be particularly valuable. Experience in any of the following would strengthen your application: combined therapeutic and diagnostic programmes, CDx development, CTIS and the EU clinical-trial environment, FDA investigational IVD or IDE frameworks, NGS or molecular pathology, central laboratory networks, multi-country submissions, and management of regulatory or Ethics Committee RFIs. You will also need excellent written and spoken English, strong project-management and organisational skills, sound judgement, and the confidence to communicate directly with international clients and study stakeholders. Most importantly, you need to be comfortable taking ownership of complex problems where the regulatory, clinical and diagnostic answers are interconnected . What success looks likeYou make complex studies feel controlled. Submission packages are coherent and country-ready. Authority and Ethics Committee questions are anticipated and answered well. Sites and testing laboratories understand what is expected. Monitoring identifies issues before they become critical. Pharmaceutical and diagnostic stakeholders remain aligned. Most importantly, the programme generates evidence that remains useful for both the therapeutic and diagnostic development objectives . Why MDx CROYou will join a Precision Medicine organisation deliberately designed to combine client-facing clinical leadership with deep scientific and technical capability across diagnostics, IVD regulation, NGS, bioinformatics, statistics and software . You will have direct client exposure, meaningful study ownership and the opportunity to work on complex international programmes where clinical, regulatory and diagnostic decisions genuinely intersect. Because this is a new position , you will also help shape how the Clinical Study Lead role develops as our Precision Medicine organisation grows.ApplyApply through LinkedIn. If you understand both the clinical trial and the diagnostic behind the biomarker, we would like to hear from you.
