argenx
1001 - 5000 employees
Founded 2008
🏥 Healthcare
💼 Consulting
🧬 Biotechnology
Healthcare • Consulting • Biotechnology
argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.
Legal Counsel, Clinical Development
🔥 2 hours ago
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argenx
1001 - 5000 employees
Founded 2008
🏥 Healthcare
💼 Consulting
🧬 Biotechnology
Healthcare • Consulting • Biotechnology
argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.
📋 Description
• Advise 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. • 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, and quality and other GxP processes. • Deliver training and practical guidance to business stakeholders on key regulatory and GxP legal topics. • Monitor regulatory and caselaw developments in the EU and other jurisdictions affecting clinical trials, pharmacovigilance, and GxP, and translate them into actionable advice.
🎯 Requirements
• Fully qualified admitted to practice in an EU jurisdiction. • Experience in life sciences or healthcare, gained in a pharmaceutical/biotech company, CRO and/or a leading law firm.
🏖️ Benefits
• Short term incentives program • Long term incentives program
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