↳Significant experience in clinical affairs, clinical operations, clinical science, or a closely related discipline within IVD or molecular diagnostics.
↳Strong exposure to IVD and CE-IVD environments; NGS experience is ideal, with molecular diagnostics experience as the minimum target background.
↳Experience designing or contributing to clinical performance studies, including protocols, clinical evidence strategy, and study reporting.
↳Experience managing CROs or strategic external partners, including reviewing outputs and driving accountability.
↳Experience working closely with regulatory teams on technical files, notified body interactions, or clinical evidence requirements.
↳Senior stakeholder presence, with the ability to engage confidently with CROs, consultants, regulatory partners, notified bodies, and biopharma partners.
↳Experience with companion diagnostics, biopharma partnerships, NGS-based diagnostics, or IVDR clinical performance documentation and submissions would be valuable.
↳A clinical or scientific background that enables you to critically assess study design, risk, and evidence requirements.
