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 perform...