Legal Counsel, Clinical Development

Legal Counsel, Clinical Development at argenx

argenx, a biotech company focused on immunology and autoimmune diseases, is hiring a Legal Counsel to support its clinical development operations. This role involves providing legal and regulatory advice on clinical trials, pharmacovigilance, and GxP compliance within the EU framework.

Key Eligibility Criteria

• Qualification: Fully qualified and admitted to practice in an EU jurisdiction.
• Experience: Proven experience in life sciences or healthcare (pharmaceutical/biotech company, CRO, or leading law firm).
• Language: Fluent in English.
• Skills: Strong knowledge of EU Clinical Trials Regulation (ECTR), ICH GCP, and pharmacovigilance regulations.

Responsibilities & Scope of Work

• Advise on legal/regulatory frameworks for clinical research (ECTR, ICH GCP).
• Support clinical operations in trial setup, conduct, and closeout (feasibility, site selection, safety reporting).
• Manage legal aspects of pharmacovigilance and interactions with health authorities (EMA, national agencies).
• Draft and negotiate life-sciences contracts (CTAs, CRO agreements, PV agreements).
• Develop internal policies, SOPs, and templates for GxP processes.

Stipend & Compensation

Not specified in the public listing. The recruiter will share the locally applicable annual base salary range during the recruitment process.

Application Procedure

1. Visit the official LinkedIn job posting.
2. Sign in or create a LinkedIn account.
3. Click Apply and submit your profile/resume.

Official Link

Apply on LinkedIn