Global Device Program Leader — Cross-Functional Delivery

Argenx; Zürich; On-site; CHF 180,000 - 280,000; Full time

Job summary

Argenx in Switzerland seeks a senior Program/Project Leader to drive device and combination-product development from concept through lifecycle management. You will own integrated project plans, manage cross-functional teams across CMC, Regulatory, Quality, Clinical, and Manufacturing, and ensure timely decisions and risk mitigation across global partnerships.

You will oversee design history file deliverables, design controls, usability, and transfer activities, partnering with asset leads to

Qualifications

• Master's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline, or equivalent experience.
• Typically 10+ years of relevant experience in pharma, biotech, or medical devices, including cross-functional leadership.
• 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.
• Excellent English communication skills; willingness to travel for partner, study, and manufacturing-site activities.

Responsibilities

• 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.
• Coordinate development of assigned solutions, including 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 planning, review, and approval of key design-control deliverables, and author selected deliverables as needed, including design inputs/outputs, design reviews, verification, validation, usability, 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.
• 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 labs, and suppliers.
• Integrate partner plans, monitor performance, and escalate quality, capacity, cost, or schedule risks early.
• 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; Regulatory and Quality retain approval accountability.
• Coordinate formative and validation human-factors activities and ensure outputs are translated into design, labeling, risk-management, and submission actions.
• Ensure compliance with internal procedures and global device and combination-product requirements.
• Collaborate with the regulatory team for device/drug submissions and assist in regulatory responses to agency requests.

Skills

Project leadership

Cross-functional leadership

Regulatory knowledge

Quality design controls

Human factors

Design transfer

Industrialization

Risk management

External partner management

Education

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

10+ years of relevant experience in pharma/biotech/medical devices

Job description

Argenx in Switzerland seeks a senior Program/Project Leader to drive device and combination-product development from concept through lifecycle management. You will own integrated project plans, manage cross-functional teams across CMC, Regulatory, Quality, Clinical, and Manufacturing, and ensure timely decisions and risk mitigation across global partnerships.

You will oversee design history file deliverables, design controls, usability, and transfer activities, partnering with asset leads to