Clinical Operations Development Lead

ppThe 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. /ph3Responsibilities /h3ulliManage clinical trial budgets, timelines and resources (including line management) and provide input to trial design and regulatory authority strategy and interactions. /liliDrive operational risk management, cross‑functional integration, problem solving and escalation. /liliLead the IDT when required, ensuring effective decision‑making and team performance toward the indication and company Objectives, Goals, Strategies and Measures (OGSMs). /liliProvide operational expertise and strategic input to the Clinical Development Plan (CDP) in collaboration with other IDT representatives. /liliEnsure the CDP describes a clinical development strategy that is innovative, effective, and consistent with the Target Product Profile (TPP). /liliProvide input to the Objectives, Goals, Strategies and Measures (OGSM). /liliBe accountable for the conduct of all clinical‑related aspects within the assigned therapeutic indication/program. /liliEnsure execution is compliant with OGSMs, timelines, budget, quality standards, ICH‑GCP, applicable regulations, SOPs and Work Instructions (WIs). /liliAct as primary point of contact for all operational clinical‑related activities at indication level and as escalation point for trial‑level activities. /liliIdentify risks in collaboration with other IDT members, ensure they are reflected in risk registers and drive mitigation. /liliWork with the Project Manager (PM) and IDT members to decide which risks and issues are brought to the asset Project Leader (PL) and Development Management Committee (DMC). /liliProactively provide solutions, oversee implementation and follow‑up. /liliEnsure that the Franchise Clinical Operations Development Lead (FCODL) and Global Head of Trial Operations are informed when an identified issue/risk could impact other therapeutic indications/programs. /liliIn asset‑specific impacts, involve FCODL, peer CODLs, AST and PM as needed. /liliEnsure consistency and efficiency in trial set‑up and conduct across different trials within the specific indication(s). /liliDrive the timely production of a qualitative Clinical Trial Protocol Concept Sheet. /liliCollaborate with Clinical Trial Leads (CTLs), Clinical Trial Managers (CTMs) and Clinical Trial Teams (CTTs) to ensure timely availability of qualitative documents defining the design and execution of the clinical program (protocol, protocol amendments, operationalization plans and tools). /liliProvide CODL input to the CTT until the team is fully resourced. /liliWork toward initial country and site selection, oversee the actual selection and ensure the AST and IDT are kept informed of the final selection. /liliParticipate in CRO and collaborator/supplier selection and management processes. /liliSupport the CTT with issue resolution in collaboration with alliance and sourcing manager if relevant. /liliReview and provide input to overarching clinical program/indication documents such as Pediatric Investigation Plan (PIP), Diversity Action Plan (DAP) and regulatory documents. /liliAccountable for clinical trial budgets and timelines and support resource requirements, collaborating with the indication PM, Finance Business Partner (FBP) and sourcing manager. /liliInform the IDT when timelines or budget deviate from projections and partner with IDT members to review status and impact of changes, propose options to resolve issues and ensure governance endorsement as needed. /liliProvide input to program dashboards to ensure accurate status updates on key milestones, issues/risks and financial status. /liliEnsure audit/inspection preparation and readiness of the assigned program/trials. /liliSupport audits and inspections. /liliSupport continuous improvement processes and consistency by sharing lessons learned across trials within the assigned therapeutic indication, across indications and across assets in collaboration with FCODL and the Global Head of Trial Operations. /liliAs a leader, set expectations, communicate transparently and clearly, and energize team members toward achieving project goals. /liliCoach CTLs/CTMs: onboard new joiners, set goals, provide continuous feedback, mentor and enable growth and development. /liliSupport Trial Operations and global company initiatives, including interviewing candidates. /liliRole‑model the argenx cultural pillars and operating principles: humility, co‑creation, drive excellence and innovation, and empower team members. /li /ulh3Skills and Competencies /h3ulliLeadership and strong internal