Senior Director, Sponsor Oversight and Monitoring Effectiveness

Dyne Therapeutics•Waltham, MA

7d•Onsite

About The Position

Dyne Therapeutics is seeking a founding leader for its Sponsor Oversight and Monitoring Effectiveness function within Clinical Operations. The Senior Director will set oversight strategy, design risk-based monitoring approaches, and provide oversight capacity and forecasting. The role safeguards investigator-site quality and evaluates CRO monitoring and key vendor activities to ensure quality, compliance, and patient focus across the clinical portfolio. The leader will establish the function’s operating model, standards, governance, analytics, and targeted oversight activities. In partnership with Clinical Operations Program and Study Leads, Clinical Business Operations, Quality Assurance, Data Management, Biostatistics, Medical, CRO partners, and key vendors, the role translates risk signals into timely recommendations, interventions, and escalations that protect participants and support reliable clinical data. It provides assurance and functional expertise while preserving Study Management’s accountability for trial execution and QA’s independent compliance responsibilities. The position is based in Waltham, Massachusetts, with travel generally less than 50%, including local, regional, and international travel.

Requirements

Bachelor’s degree in a life science, nursing, or related field.
At least 12 years of progressive responsibility in clinical operations at a biotech, pharmaceutical company, or CRO, including at least 5 years leading people managers or functional teams.
Hands-on monitoring experience as a 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 FDA and EMA expectations for sponsor oversight of CROs and other service providers.
Experience managing a CRO or other key vendors, including 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 and 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.
Ability to travel, generally less than 50%, including local, regional, and international travel.

Nice To Haves

Advanced degree (Master’s, PharmD, or PhD) or RN licensure.
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.

Responsibilities

Build Dyne’s sponsor oversight and monitoring effectiveness operating model, including governance, SOPs, templates, training, and capacity planning aligned with ICH GCP.
Create and implement Study-Specific Oversight Plans aligned with study 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.
Serve as Clinical Operations’ accountable owner for sponsor oversight of CRO monitoring and key vendor performance during audits and regulatory inspections.
Set monitoring standards using quality by design and Risk-Based Quality Management, including critical-to-quality factors, KRIs, 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 TMF and ISF completeness.
Evaluate whether monitoring activities identify material risks promptly, lead to 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 and Monitoring Effectiveness.
Safeguard investigator-site quality through risk-based surveillance, aggregate data review, and targeted Sponsor Oversight Visits.
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 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 Clinical Operations subject-matter expert for sponsor oversight and monitoring during audits and regulatory inspections, ensuring activities, decisions, escalations, and evidence are complete, traceable, and inspection-ready.
Partner with 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.