Director, Clinical Operations Program Lead

Responsibilities

• Lead the development and refinement of Program level study timelines and scenarios to contribute to strategic plans
• Provide operational status and updates to the Program team and senior leadership to support strategic decisions
• Take accountability for the operational delivery of clinical studies within a Program, ensuring quality, ethics, and cost-efficiency
• Collaborate with R&D, medical, and commercial functions to deliver on Clinical Development Plans
• Develop and execute Program strategic clinical operations plans, integrating therapeutic area science and regulatory needs
• Oversee and mentor Clinical Study Leads, trial coordinators, and vendor managers
• Drive CRO and vendor relationships to ensure execution within timelines, budget, and quality standards
• Implement risk assessment and mitigation plans through regular reviews
• Engage with KOLs, investigators, and patient advocacy groups to support clinical study activities
• Provide management, training, and coaching to direct reports

Requirements

• Undergraduate degree in a scientific or health-related discipline
• 10+ years of experience in drug development, clinical research, and operational strategy
• Proven project/program management skills including risk, timeline, and budget management
• Experience in a Biotech/Pharma environment preferred
• Experience planning and delivering global clinical programs and studies
• Experience in complex therapeutic areas; neuromuscular, rare disease, or pediatric trials preferred
• Strong leadership skills for managing matrix teams and direct reports
• Ability to travel up to 20%, including international travel

About the Company

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases using its proprietary FORCE™ platform.