Associate Director, Clinical Operations Study Lead

Responsibilities

• Manage all operational aspects of clinical studies from start-up to close-out, ensuring adherence to timelines, budget, and milestones
• Develop study-level operational strategies and clinical operations plans
• Oversee selection, management, and performance of CROs and other vendors
• Lead cross-functional teams and manage study teams in partnership with CROs
• Partner with CROs to ensure effective patient enrollment strategies
• Coordinate proactive data monitoring and maintain TMF inspection readiness
• Provide oversight of study scope, quality, and budget to internal functional leads
• Create risk assessments and mitigation plans for clinical programs

Requirements

• Undergraduate degree in a scientific or health-related discipline
• 8+ years of clinical trial management experience in Phase I-III global clinical trials
• Experience with both sponsor companies and CROs
• Solid understanding of drug development, ICH/GCP guidelines, and US/EU patient data privacy laws
• Experience in vendor selection and oversight
• Ability to manage clinical study budgets, accruals, and forecasting
• Strong leadership skills in a fast-paced matrixed environment

Preferred Qualifications

• Advanced scientific or business degree
• Experience in neuromuscular or muscle disease therapeutic areas
• Experience with rare disease or pediatric trials
• Prior site or monitoring experience

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, targeting muscle and the central nervous system (CNS) to address the root cause of disease.