Associate Director, Clinical Operations Study Lead

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. com/ , and follow us on X , LinkedIn and Facebook . Role Summary: The Clinical Operations Study Lead ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs).

Requirements

. This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory

, and Dyne’s policies ad SOPs. This individual may be responsible for one highly complex or multiple medium complexity clinical studies. This role is expected to require up to 20% travel, including international travel.

This role is based in Waltham, MA.

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Responsibilities

Include : Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities Support the selection, oversight, and management of CROs and other vendors Monitor and assess vendor performance against contractual operational deliverables.