Senior Device Program Lead, Immunology & Combo-Products

Argenx; Oost-Vlaanderen; On-site; EUR 110,000 - 170,000; Full time

Job summary

argenx is a biotechnology company transforming immunology and delivering medicines to help autoimmune patients. This Senior Project Manager role leads cross-functional teams across device projects, integrating regulatory, quality, clinical, and manufacturing inputs to drive development, industrialization, and launch readiness.

You will coordinate design controls, risk management, and documentation while managing external partners and ensuring DHF readiness.

Qualifications

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

Responsibilities

• Own integrated project plan and governance across CMC, Regulatory, Quality, Clinical, and Manufacturing.
• Lead cross-functional teams for device projects across development, industrialization, clinical supply, registration, and launch readiness.
• Coordinate development of device solutions (e.g., prefilled syringes, autoinjectors, safety systems).
• Ensure Design History File deliverables are planned, traceable, and aligned across teams and partners.

Skills

Project leadership

Cross-functional leadership

Regulatory knowledge

Quality systems

Human factors

External partnerships

English fluency

Education

Master's degree in life sciences/engineering

Job description

argenx is a biotechnology company transforming immunology and delivering medicines to help autoimmune patients. This Senior Project Manager role leads cross-functional teams across device projects, integrating regulatory, quality, clinical, and manufacturing inputs to drive development, industrialization, and launch readiness.

You will coordinate design controls, risk management, and documentation while managing external partners and ensuring DHF readiness.