Legal Counsel, Clinical Development

argenx

Legal Counsel advising on regulatory and legal frameworks for clinical research in a biotech. Supporting clinical operations and pharmacovigilance teams with compliance and contractual obligations.

Posted 7/28/2026full-timeRemote • 🇧🇪 BelgiumMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in the legal and regulatory framework for clinical research, including EU Clinical Trials Regulation and GxP compliance. Provides strategic legal support and guidance on clinical trials, pharmacovigilance, and life sciences contracts.

Highest-signal resume keywords

EU Clinical Trials Regulation (ECTR)ICH GCPPharmacovigilanceGxP ComplianceLife Sciences Contracts

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Legal SupportRegulatory GuidanceContract DraftingSafety ReportingData HandlingSite SelectionMonitoringFeasibility AssessmentRegulatory InteractionsPolicy Development

Soft Skills

Training DeliveryStakeholder Communication

Certifications & Qualifications

Qualified Lawyer in EU Jurisdiction

Industry Keywords

Clinical TrialsPharmaceuticalBiotechCROGCPGVPGMPGDPGCLPRegulatory Compliance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Short term incentives program
Long term incentives program