Clinical Operations Development Lead

📋 Description

• • Lead clinical operations for a specific therapeutic indication or across all indications of an asset, co-owning the Clinical Development Plan (CDP) with the Medical Development Lead (MDL).
• • Co-lead the Clinical Development Team (CDT), ensuring cross-functional alignment and strategic execution of clinical trials from First in Human (FIH) through registration and post-approval activities.
• • Drive the development, endorsement, and execution of the Clinical Development Plan (CDP) in alignment with the Target Product Profile (TPP), ensuring consistency with ICH-GCP, regulatory requirements, and argenx SOPs/WIs.
• • Oversee clinical trial budgets, timelines, and resource planning; provide accurate cost estimates and flag deviations to the Project Manager (PM) for timely mitigation.
• • Partner with the PM to identify, document, and mitigate risks impacting clinical timelines, budgets, or quality; escalate critical issues to the Asset Strategy Team (AST) or Development Management Committee (DMC) as needed.
• • Serve as the primary point of contact for all clinical operations related to assigned indications, ensuring seamless communication between CDT members, Clinical Trial Teams (CTTs), and global stakeholders.
• • Collaborate with the Countries and Sites Selection Commission (CSSC) to evaluate and select optimal global trial sites, incorporating input from regional teams, CTTs, and AST.
• • Participate in the selection, management, and oversight of Clinical Research Organizations (CROs) and vendors, supporting issue resolution and performance monitoring.
• • Ensure audit and inspection readiness of clinical programs; actively support regulatory audits and inspections by regulatory authorities including FDA, EMA, PMDA, and MHRA.
• • Review and provide input on critical clinical documents including Investigator Brochures (IB), Pediatric Investigation Plans (PIP), and regulatory submissions.
• • Drive consistency and efficiency across multiple trials within the same indication, promoting standardized processes and sharing lessons learned across programs.
• • Produce high-quality Clinical Trial Concept Sheets and ensure timely development of protocols, amendments, and operational tools in collaboration with CTMs and CTTs.
• • Act as line manager for Clinical Trial Managers (CTMs) and/or Clinical Trial Associates (CTAs), including interviewing, onboarding, goal setting, performance reviews, mentoring, and professional development.
• • Contribute to Objectives, Goals, Strategies and Measures (OGSM) and ensure clinical trials are executed in alignment with these targets and argenx cultural pillars.
• • Monitor program dashboards and provide accurate updates on milestones, risks, financial status, and operational progress to leadership.
• • Support global Clinical Operations initiatives and company-wide process improvements, ensuring alignment with evolving regulatory and operational standards.
• • Maintain deep expertise in ICH-GCP guidelines and global regulatory requirements, applying this knowledge to guide trial design and execution.
• • Communicate clearly and effectively in English across diverse, global teams, fostering collaboration and resolving conflicts proactively.
• • Act as a subject matter expert in clinical operations, providing strategic input during AST and CDT meetings and ensuring discipline-specific accountability for decisions.
• • May serve as Clinical Trial Manager (CTM) for one or more trials, depending on program phase and complexity, in addition to leadership responsibilities.
• • Ensure all clinical operations activities are conducted with integrity, transparency, and in full compliance with argenx values and legal requirements.