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.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
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 escalate 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, preferably from concept or platform selection through submission, approval, launch, or lifecycle management.
- 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.
- Experience with prefilled syringes, autoinjectors, safety systems, or large-volume delivery platforms is preferred.
- Experience with device assembly and industrialization towards global clinical studies and commercial launch is a plus
- Experience with device supplier engagements and change controls an asset
- Excellent English communication skills; willingness to travel for partner, study, and manufacturing-site activities.
Leadership Competencies
- Creates clarity and alignment in complex teams and builds effective relationships across functions, cultures, and external organizations.
- Balances pace, evidence, quality, cost, and risk; constructively challenges assumptions and brings the right people together early to align on options and a recommended path forward.
- This keeps the expectation of timely decision-making while emphasizing shared ownership and alignment rather than escalation.
- Communicates complex technical and project information succinctly and demonstrates ownership, sound judgment, resilience, and follow-through.
Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.
At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
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