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 TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke 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’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts.

com/ Position Purpose: The Stoke Therapeutics team is seeking an experienced and driven Director, CMC Lead to lead cross-functional teams that are accountable for chemistry, manufacturing, and controls (CMC) product lifecycle management. This individual will serve as the single point of accountability for all CMC activities, from early development through regulatory approval and commercial lifecycle management. This individual will play a central role in shaping the technical and operational direction of their assigned programs.

The CMC Lead role is a highly visible matrix team leader that provides strategic and technical leadership within CMC, while representing CMC on cross-functional Program Teams. The ideal candidate will possess strong knowledge of CMC leadership with deep understanding of process development, analytical methods, tech transfer, manufacturing, CMC regulatory strategy and health authority interactions. Additionally, this individual should possess strong interpersonal communication skills, high emotional intelligence, and be fluent in the art of negotiation.

This position will report into the Vice President, Commercial Manufacturing.

Key Responsibilities

: Provide technical and strategic leadership to cross-functional CMC development teams accountable for one or more early- and late-phase programs. Define, own and maintain a long-term development, manufacturing, and supply strategy for assigned programs, encompassing early- and late-stage CMC development, process validation, commercial readiness, product launch, and post-approval lifecycle management. , pre-filled syringe), guiding cross-functional risk assessments on drug-device compatibility, stability, and long-term performance to protect product quality and patient safety.

Partner with Manufacturing and Supply Chain to ensure manufacturing capacity and network strategies are in place to meet clinical and commercial demand. Identify and lead the assessment of technical, regulatory, quality, logistical, and financial risks associated with CMC development, manufacture, and supply, and develop corresponding mitigation strategies. Represent CMC on Program Teams for assigned products, serving as the primary CMC voice in the cross-functional program governance.

Develop long-range technical strategies to enable CMC delivery against Program Team objectives. Lead commercial product CMC lifecycle activities, including post-approval change management, product risk management, robustness improvements, and continuous improvement initiatives. Drive the creation of integrated commercial readiness plans to enable global regulatory submissions and product launches.