Associate Director, Clinical Operations Study Lead

Dyne Therapeutics seeks an Associate Director to lead clinical trial operations, translating clinical strategies into executable plans and overseeing study conduct across all phases. The role involves managing CROs, ensuring regulatory compliance, and coordinating cross-functional initiatives in support of neuromuscular disease programs.

Responsibilities

• Initiate and lead clinical trials across all development phases
• Oversee contract research organizations and vendor performance
• Develop operational plans aligned with clinical development strategy
• Ensure study conduct complies with ICH GCP and regulatory standards
• Coordinate cross-functional efforts on clinical operations initiatives

Requirements

• Clinical operations or trial management experience in drug development
• Knowledge of ICH GCP guidelines and regulatory requirements
• Experience managing clinical research organizations and external vendors
• Cross-functional collaboration and project coordination skills
• Ability to manage complex or multiple clinical studies simultaneously