Legal Counsel, Clinical Development

About the role

As a Legal Counsel in Clinical Development, you will act as a trusted partner to argenx’s clinical and safety teams, providing proactive legal guidance that enables the company to advance innovative therapies responsibly. You will work closely with cross‑functional partners to navigate complex regulatory landscapes and ensure compliance across all clinical activities.

Key responsibilities

• Advise on the legal and regulatory framework governing clinical research, including the EU Clinical Trials Regulation (ECTR), ICH GCP, and national requirements.
• Support clinical operations on trial set‑up, conduct, and close‑out, covering feasibility, site selection, monitoring, safety reporting, and data handling.
• Assist Global Patient Safety (pharmacovigilance) with regulatory obligations, safety reporting, signal management, and interactions with competent authorities.
• Provide legal counsel on GxP topics (GCP, GVP, GMP, GDP, GCLP) for investigational and marketed products, aligning quality, regulatory, and legal requirements.
• Draft, review, and negotiate life‑sciences contracts such as clinical trial agreements, CRO/vendor agreements, pharmacovigilance agreements, and collaboration contracts.
• Guide regulatory interactions with health authorities, notified bodies, and ethics committees, including responses to inspections and audits.
• Contribute to internal policy, SOP, and template development for clinical research, pharmacovigilance, and other GxP processes.
• Deliver training and practical guidance on regulatory and GxP legal topics to business stakeholders.

Required profile

• Qualified lawyer with experience in life‑sciences or pharmaceutical environments.
• Strong knowledge of EU Clinical Trials Regulation, ICH GCP, and related national regulations.
• Demonstrated expertise in GxP compliance (GCP, GVP, GMP, GDP, GCLP).
• Proven ability to draft, review, and negotiate complex clinical and vendor agreements.
• Experience supporting pharmacovigilance and regulatory interactions with health authorities.

Required skills

• EU Clinical Trials Regulation (ECTR)
• ICH Good Clinical Practice (GCP)
• GxP frameworks (GCP, GVP, GMP, GDP, GCLP)
• Clinical trial agreement drafting and negotiation
• CRO and vendor contract management
• Pharmacovigilance regulatory compliance