Legal Counsel, Clinical Development

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. Purpose of the Functionargenx’s extraordinary journey starts with an entrepreneurial spirit, and their legal function is no exception. As Legal Counsel, you will be a trusted partner to the business; not a gatekeeper, but a co-creator who helps argonauts move boldly and responsibly as they advance science and deliver innovative treatments. You will bring rigor and judgment to complex challenges, enabling new ways of working with partners, patients, and each other. The resilience and hope of patients give argenx’s work urgency; your counsel helps them pursue the biggest ideas the right way — the "argenx Way."Roles & ResponsibilitiesAdvise on the legal and regulatory framework applicable to clinical research and development activities, including EU Clinical Trials Regulation (ECTR), ICH GCP, and related national requirements.Provide legal support to clinical operations teams on the set‑up, conduct and closeout of clinical trials, including feasibility, site selection, monitoring, safety reporting, and data handling.Support Global Patient Safety (pharmacovigilance) functions on regulatory obligations, safety reporting, signal management, and interactions with competent authorities.Advise on GxP topics (e.g., GCP, GVP, GMP, GDP, GCLP and related good practices) in connection with investigational and marketed products, ensuring alignment between quality, regulatory, and legal requirements, including support in handling of GxP related matters by providing related legal advice and strategic guidance.Draft, review, and negotiate a wide range of life‑sciences contracts, including clinical trial agreements, CRO and vendor agreements, pharmacovigilance agreements, quality and technical agreements and collaboration contracts.Provide strategic guidance on regulatory interactions with health authorities (e.g., EMA, national agencies), notified bodies, and ethics committees, including responses to inspections, audits, and regulatory requests.Contribute to the development, implementation and continuous improvement of internal policies, SOPs and templates related to clinical research, pharmacovigilance, quality and other GxP processes.Deliver training and practical guidance to business stakeholders on key regulatory and GxP legal...