Device Program Lead, Drug-Delivery Systems

argenx SE

Oost-Vlaanderen

On-site

EUR 120,000 - 190,000

Full time

4 days ago
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Job summary

argenx SE in Belgium seeks a Device Project Leader to drive multi‑discipline device and combination‑product programs from initiation through development, industrialization, regulatory submission, and lifecycle management. You will coordinate cross‑functional teams, manage scope, budget, and risk, and ensure timely delivery across CMC, Regulatory, Quality, and Clinical domains.

The role requires a Master’s degree in a life sciences or related field and 10+ years in pharma/biotech or medical

Qualifications

  • Master's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline (or equivalent).
  • Typically 10+ years of relevant experience in pharma, biotech, or medical devices, including cross‑functional project leadership.

Responsibilities

  • Own the integrated project plan, including scope, deliverables, milestones, dependencies, critical path, resources, budget, risks, decisions, and escalation routes.
  • Lead the cross‑functional team for device projects, establish clear accountabilities and commitments, and drive execution across development, industrialization, clinical supply, registration, and launch readiness.
  • Monitor performance, assess scenarios and trade‑offs, initiate recovery or contingency plans, and provide concise, decision‑oriented updates to leadership and governance.
  • Lead project‑team and design‑review meetings, ensuring decisions, actions, owners, and due dates are documented and followed through.

Skills

Cross-functional leadership
Project management
Excellent English communication skills
Regulatory knowledge
Parenteral drug-product knowledge
Device development

Education

Master's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline

Job description

argenx SE in Belgium seeks a Device Project Leader to drive multi‑discipline device and combination‑product programs from initiation through development, industrialization, regulatory submission, and lifecycle management. You will coordinate cross‑functional teams, manage scope, budget, and risk, and ensure timely delivery across CMC, Regulatory, Quality, and Clinical domains.

The role requires a Master’s degree in a life sciences or related field and 10+ years in pharma/biotech or medical

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