Executive Director, Clinical Development Operations Excellence And Compliance

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), the most common inherited optic nerve disorder. 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). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach.

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. This role will drive operational excellence, department risk mitigation, and continuous process improvement to ensure clinical programs are delivered with speed, quality, and regulatory integrity. Operational Excellence is about embedding an innovative strategy to set Stoke on a path of continuous improvement. It is a focused long-term change and involves every member of the Clinical Development Operations organization, at every level.

This position will report into the Senior Vice President, Clinical Development Operations and will be part of the department's leadership team.

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 or compliance leadership role.
• Deep understanding of global clinical research regulations (ICH-GCP, FDA, EMA, PMDA, etc.).
• Proven experience driving operational excellence and quality improvement initiatives in a complex, matrixed environment.
• Strong track record in inspection readiness, audit management, and remediation planning.
• Exceptional leadership, communication, and stakeholder management skills.
• Demonstrated ability to influence at the executive level and drive cross-functional alignment.

Location(s):

Stoke is in Bedford, MA. This hybrid position is based at Stoke's Bedford, MA office, with a minimum on-site requirement of two days per week.

Travel:

This position will require approximately 25% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $286,000 - $322,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

Interested candidates: Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center:

https://www.stoketherapeutics.com/careers/

For more information, visit https://www.stoketherapeutics.com/.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.