Device Project Leader
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Job Description
Device Project Leader advancing argenx’s autoimmune drug-delivery devices and combination products. Leading cross-functional development, regulatory, industrialization, and launch-readiness programs.
Responsibilities:
- Lead assigned drug-delivery device and combination-product projects from initiation through development, industrialization, submission, launch readiness, and lifecycle management
- Translate device and product-presentation strategy into integrated project plans
- Align cross-functional teams and external partners and drive delivery against scope, quality, timeline, budget, and risk objectives
- Own project plans covering deliverables, milestones, dependencies, resources, budget, risks, decisions, and escalation routes
- Lead cross-functional device project teams across development, industrialization, clinical supply, registration, and launch readiness
- Monitor performance, assess trade-offs, initiate recovery or contingency plans, and provide leadership updates
- Lead project-team and design-review meetings and track decisions, actions, owners, and due dates
- Coordinate development of 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
- Oversee design-control deliverables 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
- Serve as the operational contact across CMC, Regulatory, Quality, Clinical, Clinical Supply, Manufacturing, Commercial, Procurement, Finance, and other functions
- Lead 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 escalate risks
- Embed regulatory, quality, design-control, risk-management, and human-factors requirements in project execution
- Coordinate device documentation and submission content and support regulatory responses
- Coordinate formative and validation human-factors activities and translate outputs into design, labeling, risk-management, and submission actions
- Ensure compliance with internal procedures and global device and combination-product requirements
Requirements:
- 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
- Substantial experience in combination-product development and cross-functional project leadership
- Experience leading multidisciplinary teams through major development milestones
- Strong working knowledge of design controls, risk management, human factors, design transfer, industrialization, and technical documentation
- Experience managing external development, technology, manufacturing, or testing partners
- Good understanding of parenteral drug-product development, primary packaging, drug-device interfaces, and regulatory expectations in major markets
- Excellent English communication skills
- Willingness to travel for partner, study, and manufacturing-site activities
Benefits:
- Short-term incentives program
- Long-term incentives program
- Equal consideration in an inclusive environment
- Equal opportunity employment
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