Clinical Operations Development Lead

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. The Clinical Operations Development Lead (CODL) is a key member of the Indication Development Team (IDT), overseeing clinical activities for a specific therapeutic indication (CODL) or across all indications for an asset (early/late phase CODL). The CODL provides operational input and drives strategy for clinical development across the lifecycle of an asset, from First in Human (FIH) studies through registration and post-approval clinical development activities. Responsibilities include but not limited to: managing clinical trial budgets, timelines, and resources (including line management), and providing input to trial design and regulatory authority strategy and interactions The CODL drives operational risk management, cross-functional I implementation, problem solving and escalation. The CODL may lead the IDT, ensuring effective decision-making and team performance towards the indication and company Objectives, goals, strategies and measures (OGSMs). ROLES AND RESPONSIBILITIES (non-exhaustive list) - Provides operational expertise and strategic input to the Clinical Development Plan (CDP) in collaboration with other IDT representatives. Ensures the CDP describes the clinical development strategy, comprising effective and, where possible, innovative trial designs and is consistent with the Target Product Profile (TPP). - Provides input to the Objectives, Goals, Strategies and Measures (OGSM). - Accountable for the conduct of all clinical related aspects within the assigned therapeutic indication/program. Ensure the execution is done in line with the agreed OGSMs, timelines, budget, quality standards, ICH-GCP and applicable regulations, Standard Operation Procedures (SOPs) and Work Instructions (WIs). - Act as primary point of contact for all operational clinical related activities at indication level and as escalation point for trial level activities. - In collaboration with the other IDT members, identifies risks, ensures that these are reflected in applicable risk registers and drives their mitigation. Works with the Project Manager (PM) and IDT members to decide which risks and issues are to be brought to the attention of the asset Project Leader (PL) and the Development Management Committee (DMC). Pro-actively provides solutions and oversees implementation and follow-up. - Ensures that the Franchise Clinical Operations Development Lead (FCODL) and Global Head of Trial Operations are informed in case an identified issue/risk could have an impact on/may also occur in the other therapeutic indications/programs. In case of an asset specific impact, involve FCODL and peer CODL(s), AST, and PM as needed. - Ensures consistency and efficiency in trial set-up and conduct across the different trials within the specific indication(s). - Drives the timely production of a qualitative Clinical Trial Protocol Concept Sheet. - Collaborates with the Clinical Trial Leads (CTLs) and Clinical Trial Managers (CTM) and their respective Clinical Trial Teams (CTTs) to ensure timely availability of qualitative documents defining the design and the execution of the clinical program (e.g. protocol/protocol amendments, operationalization plans and tools). Active CODL input to the CTT may be needed until the tea