Executive Director, Clinical Development Operations Excellence and Compliance

Executive Director, Clinical Development Operations Excellence and Compliance

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About Stoke: Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary approach, the company is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study.

Stoke entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico;
Biogen receives exclusive rest of world commercialization rights. STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA). STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.

Stoke’s initial focus is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency).

Position

Purpose:

The Executive Director, Clinical Development Operations Excellence and Compliance, is a senior operational leader responsible for elevating the efficiency, quality, and compliance of clinical development operations execution. This role focuses on optimizing operational performance, embedding compliance by design, and ensuring global consistency in processes, systems, and governance frameworks across Clinical Development Operations and Clinical Development. The role will drive operational excellence, department risk mitigation, and continuous process improvement to ensure clinical programs are delivered with speed, quality, and regulatory integrity.

Key Responsibilities:

• Partner with functional leaders to refine and optimize processes that elevate operational excellence and compliance across clinical trials, ensuring efficiency, consistency, and high-quality delivery.
• Establish and maintain harmonized, scalable processes and other solutions that improve executional quality and cycle time.
• Integrate regulatory and GCP requirements into operational practices to ensure proactive compliance and inspection readiness.
• Identify, prioritize, and lead initiatives that strengthen operational capability and organizational learning across clinical development operations.
• Collaborate with Clinical Development, Regulatory, Quality, and other applicable functions to align processes, mitigate operational risk, and support portfolio execution.
• Build/connect interface between SOP/process owners and functional leaders across Clinical Development Operations and Clinical Development as needed.
• Champion digital innovation, process simplification, and change management to modernize how clinical trials are delivered.
• Participate in governance committees related to operational excellence, clinical compliance, and risk management.
• Oversee internal audit readiness for Clinical Development Operations and support inspection management across global trials; support Clinical Study Teams with proactive risk mitigation and CAPA implementation as needed.
• Implement and lead an oversight and monitoring strategy to ensure consistent visibility into clinical execution quality, operational risk, and compliance performance across programs.
• Establish and lead a Clinical Development Operations Compliance Committee with managers and key study leads to review study quality, deviations, and regulatory compliance.

Required

Skills & Experience:

• Degree in Life Sciences, or a related field with 18+ years of experience in Clinical Development Operations or Clinical Operations, with at least 10 years in a senior operational…