Senior Device & Combo-Product Project Lead

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

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