argenx
1001 - 5000 employees
Founded 2008
🧬 Biotechnology
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.
Clinical Operations Development Lead
🕒 February 18
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argenx
1001 - 5000 employees
Founded 2008
🧬 Biotechnology
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
• 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). • 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. • 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).
🎯 Requirements
• Bachelor’s or master’s degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience. • Minimum of 15 years of leadership experience in Clinical Development (monitoring, local and global/international trial management). • Experience in working in an outsourced model, including overseeing CROs and collaborators. • Rare disease and/or auto-immune clinical trial background is a plus.
🏖️ Benefits
• Competitive salary • Professional development opportunities
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