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 Function

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

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors including but not limited to internal equity prior education and experience job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.

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.

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