Senior Device & Combination-Product Program Lead

Argenx; Oost-Vlaanderen; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Incentives program

Job summary

argenx is seeking a Device Project Leader to drive one or more drug-delivery device projects from initiation to launch readiness and lifecycle management. You will translate strategy into integrated plans, align cross-functional teams, and leverage partnerships with CDMOs and suppliers to deliver against scope, cost, and quality targets.

The role requires senior-level experience in combination-product development, strong design-control expertise, and excellent English communication across global

Qualifications

• Master’s degree in life sciences, engineering, pharmaceutical sciences, or equivalent.
• Typically 10+ years in pharma/biotech/medical devices with combo-product experience.
• Experience leading multidisciplinary teams through major development milestones.
• Strong knowledge of design controls, risk management, human factors, and documentation.
• Experience managing external development, manufacturing or testing partners.
• Understanding of parenteral drug-product development and regulatory expectations.
• Experience with prefilled syringes, autoinjectors, safety systems, or large-volume delivery.
• Excellent English communication and willingness to travel.

Responsibilities

• Lead one or more device-delivery projects from initiation through lifecycle management.
• Coordinate cross-functional teams across CMC, Regulatory, Quality, and Clinical.
• Drive delivery against scope, quality, timeline, budget, and risk objectives.
• Lead design-control deliverables including inputs/outputs, reviews, verification, and validation.
• Manage external partners and suppliers; escalate risks early.
• Maintain design history file alignment and governance updates.

Skills

Project leadership

Cross-functional collaboration

English communication

Education

Master’s degree in life sciences/engineering/pharma

Job description

argenx is seeking a Device Project Leader to drive one or more drug-delivery device projects from initiation to launch readiness and lifecycle management. You will translate strategy into integrated plans, align cross-functional teams, and leverage partnerships with CDMOs and suppliers to deliver against scope, cost, and quality targets.

The role requires senior-level experience in combination-product development, strong design-control expertise, and excellent English communication across global