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Biotech
Lead ongoing safety surveillance and signal detection for investigational and marketed products. Analyze aggregated safety data, leverage analytics/AI outputs, support benefit-risk assessments, draft periodic safety reports, and collaborate cross-functionally to maintain compliance with global pharmacovigilance requirements.
Biotech
Lead configuration, maintenance, and operation of safety databases (Argus) and related systems to ensure compliant case processing, reporting, and analytics. Support system validation, generate and QC aggregate reports and line listings, collaborate with PV/clinical/regulatory teams and vendors, contribute to SOPs and audit readiness, and continuously improve safety data workflows and integrations.
Biotech
Lead clinical development strategy and execution for assigned therapeutic indications, co-chair Clinical Development Team, oversee trial design, budgets, timelines, CRO/vendor management, risk mitigation, and regulatory interactions. May line-manage CTMs/CTAs, act as CTM for select trials, ensure ICH-GCP compliance, audit readiness, and cross-functional alignment across the program lifecycle.
Biotech
Lead US rheumatology insights strategy: design and execute qualitative and quantitative research, synthesize multi-source data, advise cross-functional leadership, manage vendors and budget, and translate insights into go-to-market recommendations to support market development and launches.
