Senior Director, Sponsor Oversight and Monitoring Effectiveness

The posting, as Dyne Therapeutics wrote it

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

[…]
perience hosting or supporting regulatory inspections

• Executive presence, with a record of turning risk signals into clear recommendations for senior leaders
• Demonstrated experience building capabilities and leading direct reports, subject-matter experts, consultants, or matrixed teams
• Experience establishing a new sponsor oversight, RBQM, or centralized monitoring capability
• Experience with global Phase 2/3 or registration-enabling studies
• Rare disease, pediatric, neuromuscular, or genetic-medicine experience
• Experience operating in a hybrid outsourcing model
• Experience with RBQM platforms, clinical analytics, CTMS, EDC, and eTMF data
• Experience evaluating CRA capacity, quality, and monitoring-model effectiveness
• Experience with FDA BIMO or comparable global GCP inspections
• Experience supporting major regulatory submissions
• Ability to travel (generally less than 50%, including local, regional, and international)

#LI-Onsite
MA Pay Range
$260,000 — $295,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.