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.
- Communicate oversight findings to study teams, CROs, key vendors, and Clinical Operations leadership, escalating significant quality issues through established governance.
- Define and monitor CRO and Functional Service Provider (FSP) expectations for CRA qualifications, training, workload, continuity, visit execution, report quality, issue escalation, and corrective-action effectiveness.
- Define and monitor key vendor expectations for qualified personnel, training, system validation, data quality, turnaround times, issue escalation, and corrective-action effectiveness.
- Serve as the Clinical Operations subject-matter expert for sponsor oversight and monitoring during audits and regulatory inspections, ensuring oversight activities, decisions, escalations, and evidence are complete, traceable, and inspection-ready.
Collaborate across functions and governance
- Partner with Clinical Operations Program Leads (COPLs), study teams, Clinical Business Operations, QA, Medical, Data Management, Biostatistics, Clinical Systems, and Portfolio Analytics & Systems to integrate operational, clinical, and quality data into actionable risk signals.
- Translate risk signals into fit-for-purpose monitoring and oversight interventions in partnership with study teams, CROs, and key vendors.
- Report portfolio oversight status, trends, risks, and recommendations to leadership and CRO and key vendor governance forums.
- Model Dyne’s values and leadership expectations by fostering trust, collaboration, inclusion, accountability, and high performance.
Education and Skills Requirements:
- Bachelor’s degree in a life science, nursing, or related field required. Advanced degree (Master’s, PharmD, or PhD) or RN licensure preferred
- 12+ years of progressive responsibility in clinical operations at a biotech, pharma, or CRO, including at least 5 years leading people managers or functional teams
- Hands-on monitoring experience as a Clinical Research Associate (CRA) or monitoring manager, plus direct experience overseeing CRO monitoring
- Proven delivery of RBQM, centralized monitoring, or quality-by-design programs
- Deep working knowledge of ICH E6(R3), ICH E8(R1) General Considerations for Clinical Studies, and Food and Drug Administration (FDA) and European Medicines Agency (EMA) expectations for sponsor oversight of CROs and other service providers
- Experience managing a CRO, or other key vendors: scope, metrics, invoices, and forecasting.
- Direct experience overseeing key clinical trial vendors beyond the CRO, such as central laboratories, imaging, physical therapy, and other providers.
- Direct experience 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
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.
