Device Project Leader

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

Job summary

argenx is recruiting a Device Project Leader to drive one or more drug-delivery device projects from initiation through development, industrialization, submission, and lifecycle management. You will translate strategy into an integrated plan and lead cross-functional teams across development, regulatory, and manufacturing to ensure on-time delivery.

The role requires a Master’s degree and 10+ years in pharma/biotech/medical devices with a track record in combination-product projects and

Qualifications

• Master's degree or equivalent experience.
• 10+ years in pharma/biotech/medical devices with experience in combination-product development and cross-functional leadership.
• Experience leading multidisciplinary teams through major development milestones.

Responsibilities

• Own the integrated project plan with scope, milestones, dependencies, resources, budget, risks, decisions and escalation routes.
• Lead cross-functional device projects across development, industrialization, clinical supply, registration and launch readiness.
• Monitor performance, assess scenarios and drive contingency plans; provide concise updates to leadership.
• Lead project-team and design-review meetings with documented actions, owners and due dates.
• Coordinate development of devices such as prefilled syringes, safety systems, autoinjectors and delivery systems.
• Integrate user, product, technical, manufacturing, quality, regulatory, clinical and commercial requirements into the plan.
• Oversee design-control deliverables and author design inputs/outputs, reviews, verification, validation, usability, risk management, transfer and documentation.
• Ensure Design History File deliverables are traceable and aligned across teams and partners.
• Embed regulatory, quality, risk management and human-factors requirements in planning and execution.
• Collaborate with regulatory for submissions and responses.

Education

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

Job description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

Purpose of the Role

The Device Project Leader is accountable for leading one or more assigned drug-delivery device and combination-product projects from initiation through development, industrialization, submission, launch readiness, and lifecycle management. The role translates the endorsed device and product-presentation strategy into an integrated project plan, aligns cross-functional teams and external partners, and drives delivery against scope, quality, timeline, budget, and risk objectives. Functional experts retain accountability for the technical quality and approval of deliverables within their disciplines.

Key Accountabilities

Project Leadership and Delivery

• 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.

Device and Combination-Product Development

• Coordinate development of assigned solutions, which may include prefilled syringes, safety systems, autoinjectors, large-volume or on-body delivery systems, secondary packaging, and instructions for use.
• Integrate user, product, technical, manufacturing, quality, regulatory, clinical, and commercial requirements into the development approach and project plan.
• Oversee the planning, review, and approval of key design-control deliverables, and author selected deliverables as needed, including design inputs and outputs, design reviews, verification, validation, usability engineering, risk management, design transfer, and technical documentation.
• Ensure Design History File deliverables are planned, assigned, traceable, review-ready, and aligned across internal teams and external partners.

Cross-Functional and External Leadership

• Act as the central operational point of contact for assigned projects across CMC, Regulatory, Quality, Clinical, Clinical Supply, Manufacturing, Commercial, Procurement, Finance, and other relevant functions.
• Partner with the CMC or asset lead and Device Capability Lead to convert the endorsed platform and product strategy into project objectives, plans, and recommendations.Lead day-to-day project governance with device manufacturers, technology partners, CDMOs, testing laboratories, human-factors providers, consultants, and packaging suppliers.
• Integrate partner plans and deliverables, contribute to statements of work and budgets, monitor performance, and elevate quality, capacity, cost, or schedule risks early.

Regulatory, Quality, and Human Factors Integration

• Embed regulatory, quality, design-control, risk-management, and human-factors requirements in project planning and execution.
• Coordinate timely availability and review of device source documentation and submission content, while Regulatory and Quality retain functional approval accountability.
• Coordinate formative and validation human-factors activities and ensure outputs are translated into design, labeling, risk-management, and submission actions.
• Ensure project activities follow applicable internal procedures and relevant global device and combination-product requirements.
• Collaborate with the regulatory team for device/drug regulatory submissions and assist in formulating regulatory responses to agency requests for information.

Experience and Qualifications

• Master's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline, or equivalent relevant experience.
• Typically 10+ years of relevant experience in pharma, biotech, or medical devices, including substantial experience in combination-product development and cross-functional project leadership.
• Demonstrated experience leading multidisciplinary teams through major development milestones, prefer