Device Program Lead – Drug Delivery & Combo Products

argenx US Inc; Belgique; On-site; EUR 120,000 - 170,000; Full time

Job summary

argenx seeks a seasoned Device Project Leader to drive one or more device and combination-product programs from initiation through development, industrialization, submission, launch readiness, and lifecycle management in a cutting-edge biotech setting in Belgium.

You will translate strategy into integrated plans, align cross-functional teams, manage risks and timelines, and ensure design controls and documentation meet regulatory expectations across major markets.

Qualifications

• Master's degree in life sciences, engineering, pharma, or related field.
• 10+ years in pharma, biotech, or medical devices with cross-functional leadership.
• Experience with combination-product development.
• Strong knowledge of design controls, risk management, human factors.
• Excellent English communication; willingness to travel.

Responsibilities

• Own the integrated project plan with scope, milestones, budget, and risks.
• Lead cross-functional device projects across development, industrialization, regulatory, and launch readiness.
• Monitor performance, assess scenarios, and provide updates to leadership.
• Lead design-review meetings; ensure actions and due dates are tracked.
• Coordinate development of device solutions (pre-filled syringes, autoinjectors, etc.).
• Embed regulatory, quality, and human-factors requirements in planning and execution.

Skills

Project leadership

Cross-functional collaboration

English communication skills

Strategic thinking

Willingness to travel

Education

Master's degree (life sciences / engineering / pharma)

Job description

argenx seeks a seasoned Device Project Leader to drive one or more device and combination-product programs from initiation through development, industrialization, submission, launch readiness, and lifecycle management in a cutting-edge biotech setting in Belgium.

You will translate strategy into integrated plans, align cross-functional teams, manage risks and timelines, and ensure design controls and documentation meet regulatory expectations across major markets.