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hace 1 mes
Head of Clinical Research at MDx CROAre you ready to lead clinical excellence and shape the future of medtech innovation?MDx is seeking a visionary Head of Clinical Research to design and implement strategies that guarantee Safety, Performance and Effectiveness for medical devices, in vitro diagnostics (IVDs), and Companion Diagnostics (CDx). This is an opportunity to influence global healthcare and drive innovation in a dynamic, collaborative environment.Role SummaryAs Head of Clinical Research, you will be the cornerstone of MDx’s clinical operations. Your mission will be to define and oversee strategies that ensure compliance with MDR, IVDR, CTR, and FDA requirements, while delivering robust evidence of safety and performance. You will lead global clinical projects, uphold Good Clinical Practice (GCP) standards, and strengthen MDx’s reputation as a trusted partner in medtech innovation.You will not be alone in this mission. Behind you stands a strong organisational structure including Directors, Managers, Clinical Leads, Biostatistics experts, and Data Management teams, providing the expertise and resources needed to deliver excellence.What You Will DoDevelop and implement clinical research strategies aligned with international regulatory frameworks.Oversee complex, multi-country clinical projects, including CDx studies and laboratory-based validations.Ensure compliance with GCP and ISO standards (ISO 14155, ISO 20916).Drive risk management and continuous improvement within the Quality Management System.Collaborate with sponsors and internal stakeholders to achieve project success.Represent MDx in high-level discussions with regulatory bodies and strategic partners.What We Are Looking ForExperience: Minimum 8 years in clinical research or regulatory leadership within medtech, IVD, or pharmaceutical sectors.Regulatory Expertise: Deep understanding of MDR, IVDR, CTR, FDA, and ISO standards.Technical Skills: Strong knowledge of biostatistics, data management principles, and clinical trial design.Project Management: Proven ability to manage multi-country trials and complex timelines.Leadership: Track record of building and mentoring high-performing teams.Education: Bachelor’s and Master’s in life sciences; Ph.D. preferred.Language: Advanced English (C1–C2 level); additional languages are a plus.Soft Skills: Strategic thinking, problem-solving, stakeholder engagement, and adaptability in a fast-paced environment.Laboratory Background: Hands-on experience with laboratory workflows and CDx development.Why Join MDx?At MDx, we believe in innovation, diversity, and continuous improvement. You will work remotely with flexibility, supported by cutting-edge tools and a collaborative culture that makes a real impact on global healthcare. This is your chance to lead transformative projects and contribute to a vision that improves lives worldwide.Our VisionAt MDx, we are committed to shaping the future of medtech innovation. Our mission is to make advanced medical technologies accessible and impactful worldwide. #Make it POSSIBLE | #Make it WIN-WIN | #Keep IMPROVING | #Keep GROWING | #Keep DIVERSE👉 Ready to make it possible? Apply now and lead the future of clinical research
