Device Project Leader

pJoin 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. /p h3Purpose of the Role /h3 h3Key Accountabilities /h3 h3Project Leadership and Delivery /h3 ul liOwn the integrated project plan, including scope, deliverables, milestones, dependencies, critical path, resources, budget, risks, decisions, and escalation routes. /li liLead the cross-functional team for device projects, establish clear accountabilities and commitments, and drive execution across development, industrialization, clinical supply, registration, and launch readiness. /li liMonitor performance, assess scenarios and trade-offs, initiate recovery or contingency plans, and provide concise, decision-oriented updates to leadership and governance. /li liLead project-team and design-review meetings, ensuring decisions, actions, owners, and due dates are documented and followed through. /li /ul h3Device and Combination-Product Development /h3 ul liCoordinate 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. /li liIntegrate user, product, technical, manufacturing, quality, regulatory, clinical, and commercial requirements into the development approach and project plan. /li liOversee 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. /li liEnsure Design History File deliverables are planned, assigned, traceable, review-ready, and aligned across internal teams and external partners. /li /ul h3Cross-Functional and External Leadership /h3 ul liAct 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. /li liPartner 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. /li liIntegrate partner plans and deliverables, contribute to statements of work and budgets, monitor performance, and escal quality, capacity, cost, or schedule risks early. /li /ul h3Regulatory, Quality, and Human Factors Integration /h3 ul liEmbed regulatory, quality, design-control, risk-management, and human-factors requirements in project planning and execution. /li liCoordinate timely availability and review of device source documentation and submission content, while Regulatory and Quality retain functional approval accountability. /li liCoordinate formative and validation human-factors activities and ensure outputs are translated into design, labeling, risk-management, and submission actions. /li liEnsure project activities follow applicable internal procedures and relevant global device and combination-product requirements. /li liCollaborate with the regulatory team for device/drug regulatory submissions and assist in formulating regulatory responses to agency requests for information. /li /ul h3Experience And Qualifications /h3 ul liMaster's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline, or equivalent relevant experience. /li liTypically 10+ years of relevant experience in pharma, biotech, or medical devices, including substantial experience in combination-product development and cross-functional project leadership. /li liDemonstrated experience leading multidisciplinary teams through major development milestones, preferably from concept or platform selection through submission, approval, launch, or lifecycle management. /li liStrong working knowledge of design controls, risk management, human factors, design transfer, industrialization, and technical documentation. /li liExperience managing external development, technology, manufacturing, or testing partners. /li liGood understanding of parenteral drug-product development, primary packaging, drug-device interfaces, and regulatory expectations in major markets. /li liExperience with prefilled syringes, autoinjectors, safety systems, or large-volume delivery platforms is preferred. /li liExperience with device assembly and industrialization towards global clinical studies and commercial launch is a plus /li liExperience with device supplier engagements and change controls an asset /li liExcellent English communication skills; willingness to travel for partner, study, and manufacturing-site activities. /li /ul h3Leadership Competencies /h3 ul liCreates clarity and alignment in complex teams and builds effective relationships across functions, cultures, and external organizations. /li liBalances 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. /li liThis keeps the expectation of timely decision-making while emphasizing shared ownership and alignment rather than escalation. /li liCommunicates complex technical and project information succinctly and demonstrates ownership, sound judgment, resilience, and follow-through. /li /ul pNote: 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. /p pThis job is eligible to participate in our short-term and long-term incentives program. /p pThe 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. /p pAt 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. /p pBefore you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at /p #J-18808-Ljbffr