Device Project Leader

Job not on LinkedIn

🔥 0 minutes ago

🇨🇭 Switzerland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• 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