Legal Counsel, Clinical Development

argenx SE; Oost-Vlaanderen; Sur place; EUR 120 000 - 210 000; Plein temps

Résumé du poste

argenx SE is seeking a Legal Counsel to advise on clinical research regulatory and GxP matters. You will support clinical operations, pharmacovigilance and quality teams, and negotiate diverse life-sciences contracts across regions.

You will work with cross-functional stakeholders, translating evolving regulatory guidance into practical, risk-balanced advice in a fast-paced biotech environment.

Qualifications

• Deep knowledge of clinical trials, pharmacovigilance and GxP requirements.
• Experience with EMA/national authorities and regulatory inspections.
• Proven ability to draft and negotiate clinical trial, vendor and safety contracts.

Responsabilités

• Advise on legal and regulatory frameworks for clinical research and development.
• Provide legal support to clinical operations during trials, including safety reporting and data handling.
• Support pharmacovigilance functions and regulatory obligations.
• Advise on GxP topics across products and quality processes.
• Draft, review and negotiate a wide range of life-sciences contracts.
• Guide regulatory interactions with authorities and ethics committees.
• Develop internal policies, SOPs and training on regulatory/GxP topics.
• Monitor EU and other jurisdictions' regulatory changes and translate to practical advice.

Connaissances

Regulatory knowledge

GxP guidance

Contract negotiation

Cross-functional collaboration

English proficiency

Formation

EU-qualified lawyer

Life sciences/pharma experience

Description du poste

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 Function argenx’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 & Responsibilities

• 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, 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 topics, including new and evolving legislation and authority guidance.
• Monitor regulatory and caselaw developments in the EU and relevant other jurisdictions affecting clinical trials, pharmacovigilance, and GxP, and translate them into actionable advice.

Skills & Competencies

• In-depth knowledge of life sciences regulatory framework, including clinical trials, pharmacovigilance, and GxP requirements; experience with EMA and national competent authorities is a strong asset.
• Demonstrated experience supporting clinical operations and pharmacovigilance teams, including negotiating CTAs, vendor contracts and safety or quality agreements.
• Excellent analytical skills and the ability to provide pragmatic, business-oriented and risk-stratified solutions in a complex, fast-changing regulatory environment.
• Strong communication and stakeholder management skills, with the ability to influence and build trust across functions.
• Fluent in English
• Ability to work collaboratively and effectively together within cross-functional teams and networks.
• Demonstrated communication skills, within a multi-cultural and multi-lingual global environment.
• Agility and adaptability, comfort with ambiguity, trust-building, and resilience.
• Derives energy from operating in a dynamic, complex, fast-moving, and frequently changing business environment.
• Demonstrated experience with project management, proactive planning, priority setting, and securing alignment Drives toward outcomes.
• Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness to continuously learn, self-improve and develop.
• This includes being comfortable giving and receiving feedback in a diverse environment.
• Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility.

Education & Experience

• 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.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

• This job is eligible to participate in our short-term and long-term incentives program.

argonx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility.