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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary

The Senior Director, Sponsor Oversight and Monitoring Effectiveness (SOME) is the founding leader of this function within Clinical Operations. This leader sets oversight strategy, designs risk-based monitoring approaches, and provides oversight capacity, including its forecasting. The role safeguards investigator site quality and confirms key vendor activities, and CRO monitoring meets the highest standards of quality, compliance, and patient focus. This leader develops the operating model, standards, governance, analytics, and targeted oversight activities used to evaluate CRO monitoring, investigator-site quality, and emerging clinical trial risks across Dyne’s portfolio.

Working in close partnership with Clinical Operations Program and Study Leads, Clinical Business Operations, Quality Assurance, Data Management, Biostatistics, Medical, CRO partners and key vendors, this role translates risk signals into timely recommendations, interventions, and escalations that protect participants and support reliable clinical data. The role provides assurance and functional expertise while preserving Study Management’s accountability for trial execution and Quality Assurance’s independent compliance responsibilities.

This role is based in Waltham, MA.

Primary Responsibilities Include:

Build the capability and own oversight strategy

Design and establish Dyne’s sponsor oversight and monitoring effectiveness operating model, including governance, Standard Operating Procedures (SOPs), templates, training, and capacity planning aligned with ICH GCP.
Create and implement Study-Specific Oversight Plans (SSOPs) aligned with each study’s risk management and monitoring plans, covering CRO monitoring and key vendors.
Establish standards for assurance, escalation, and targeted intervention while maintaining clear accountability within Clinical Operations and partnership with Quality Assurance (QA).
Serve as Clinical Operations’ accountable owner for sponsor oversight of CRO monitoring and key vendor performance during audits and regulatory inspections.

Design and drive monitoring strategy

Set Dyne’s monitoring standards using quality by design and Risk-Based Quality Management (RBQM), including critical-to-quality factors, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and centralized monitoring.
Shape CRO monitoring plans during protocol development and study start-up to protect patient safety and data integrity.
Analyze site and study risk, identify emerging issues, and drive timely intervention and corrective action.
Establish and track monitoring-effectiveness metrics, including visit report timeliness, action-item closure, protocol deviation detection, and Trial Master File (TMF) and Investigator Site File (ISF) completeness.
Evaluate whether monitoring activities identify material risks in a timely manner, result in appropriate corrective action, and improve patient safety, protocol compliance, and data reliability.
Shape the monitoring model as Dyne transitions to a hybrid outsourcing model.

Provide functional leadership across Sponsor Oversight & Monitoring Effectiveness

Safeguard quality at investigator sites through risk-based surveillance, aggregate data review, and targeted Sponsor Oversight Visits (SOVs).
Develop a portfolio-level view of site, study, CRO monitoring, and key vendor risk; identify cross-study trends and systemic issues; and recommend enterprise-level interventions and process improvements.