Overview

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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 are 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 implementation, problem solving and escalation. The CODL may lead the IDT, ensuring effective decision-making and team performance towards the indication and company OGSMs.

Responsibilities




- 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

📌 Clinical Operations Development Lead (Lima)
🏢 argenx
📍 Lima