Senior Director, Sponsor Oversight and Monitoring Effectiveness

The role

The Senior Director, Sponsor Oversight and Monitoring Effectiveness is the founding leader of this function within Clinical Operations. This person will design oversight strategy, establish monitoring standards, and manage CRO and vendor performance to safeguard investigator site quality.

What you will do

• Design and establish the sponsor oversight and monitoring effectiveness operating model
• Create and implement Study-Specific Oversight Plans (SSOPs)
• Serve as Clinical Operations owner for sponsor oversight of CRO monitoring and vendor performance
• Set monitoring standards using quality by design and Risk-Based Quality Management (RBQM)
• Analyze site and study risk and drive timely intervention
• Establish and track monitoring-effectiveness metrics
• Safeguard quality at investigator sites through risk-based surveillance and Sponsor Oversight Visits (SOVs)
• Develop a portfolio-level view of site, study, CRO, and vendor risk
• Communicate oversight findings to study teams and leadership
• Define and monitor CRO and Functional Service Provider (FSP) expectations

Required qualifications

• Bachelor’s degree in a life science, nursing, or related field
• 12+ years of progressive responsibility in clinical operations at a biotech, pharma, or CRO
• At least 5 years leading people managers or functional teams
• Hands-on monitoring experience as a Clinical Research Associate (CRA) or monitoring manager
• 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
• Experience managing a CRO, or other key vendors: scope, metrics, invoices, and forecasting
• Direct experience overseeing key clinical trial vendors beyond the CRO
• Direct experience hosting or supporting regulatory inspections
• Executive presence
• Demonstrated experience building capabilities and leading direct reports, subject-matter experts, consultants, or matrixed teams

Nice to have

• Advanced degree (Master’s, PharmD, or PhD)
• RN licensure
• Rare disease, pediatric, neuromuscular, or genetic-medicine experience

About the company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for other diseases.