Senior Director, Corporate Quality

Senior Director, Corporate Quality

Stoke Therapeutics 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.

The Senior Director, Corporate Quality is responsible for ensuring the effectiveness and continuous improvement of Stoke's Quality Management System (QMS) throughout the product lifecycle from clinical development to commercialization in compliance with global regulations and guidelines. This person will be responsible for providing strategic and operational leadership for the quality systems function at Stoke, expanding Stoke's QMS and leading Quality Governance. This person is expected to influence Stoke's quality culture to help reach a sustained state of inspection readiness for all GxP (GMP, GCP, GLP, GVP) activities. This person will also oversee Stoke's GxP vendor management and audit programs and manage any regulatory inspections at Stoke. This role will report to the Vice President of Quality and will interface closely with other cross-functional groups such as CMC, Clinical Development, Clinical Development Operations, Program Management, Regulatory, Commercial, IT and other functions within Quality.

Key Responsibilities:

• Aligned with CMC and Clinical Development, establish and lead Stoke's global compliance strategy for all stages of product development and clinical trial management.
• Act as a compliance expert and thought partner to senior leadership.
• Accountable for the end-to-end oversight of Stoke's QMS that spans the entire product lifecycle and its application to all disciplines of GxP.
• Oversee the development, implementation, and ongoing effectiveness of Stoke's QMS in alignment with regulatory expectations across all enterprise functions.
• Responsible for establishing the processes and communication mechanisms for regulatory intelligence to assess emerging global regulatory expectations for impact on the organization and Stoke's QMS to ensure ongoing compliance.
• Establish Quality Governance at an enterprise level by setting meaningful quality metrics and KPIs to monitor performance and sustain improvement.
• Oversee SOP governance, document control, training management, change management, risk management, data integrity, and GxP computer systems validation.
• Represent quality on project teams, as needed and provide GxP compliance interpretation, consultation to maintain and improve compliance to ensure product quality, data integrity and patient safety.
• Oversee Stoke's Internal and External Audit Program to coordinate required audits, monitor for signals and trends and ensure the implementation of appropriate CAPAs.
• Help train/prepare Stoke GMP employees for regulatory inspections and host GMP and BIMO regulatory inspections, as necessary, and provide input and review of responses to inspection related regulatory agency questions.
• Establish and oversee Stoke's Quality / Regulatory intelligence process to ensure that regulations, standards, and industry best practices are implemented.
• Partner with CMC, QA, Regulatory Affairs and Program Teams to ensure Quality strategies support overall development and commercial strategy.
• Champion Stoke's Quality culture.
• Lead, mentor, and develop a small team of quality professionals responsible for the administration and management of Stoke's QMS and compliance management program.
• Provide expert oversight in guiding remediation and regulatory communications.

Required Skills & Experience:

• BS/BA, MS in life sciences (i.e., Chemistry, Biology, Engineering disciplines) with 15+ years progressive experience in Biotech or Pharma setting with experience in either developing, implementing and/or managing GxP Quality Systems.
• Strong working knowledge of global GxP regulations (FDA, EU, ICH) and guidelines necessary for phase appropriate decision making and representation to regulatory agencies.
• Proficient in interpreting GxP regulations toward implementing quality systems for GxP applications in a practical manner.
• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
• Experience developing strategy and guiding teams to translate strategy into action
• Proven ability to build scalable, fit for purpose GxP processes in a lean environment
• Experience dealing with FDA and other major regulatory agencies and leading or participating in hosting regulatory inspections.
• Possess excellent analytical skills and the ability to communicate complex issues clearly to a broad group of people.
• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based pragmatic decisions in a timely manner.
• Hands-on experience managing small teams, and in providing coaching, development and mentoring to employees.

Location(s): Stoke is located in Bedford, MA. This position is a hybrid position with an office based in Bedford, MA location.

Travel: This position will require approximately 5-10 % 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 $254,000 - $290,000. 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.