Director, Clinical Quality Operations

About Stoke:

Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. 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 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

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

Stoke has identified STK-002 as a clinical candidate for the potential treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. The company is also pursuing a potential new medicine for Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.

Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company’s proprietary approach.

Position Purpose:

The Director, Clinical Quality Compliance will be the primary quality contact for GCP and GCLP compliance. This role will report into The VP of Quality and will interface closely with other cross-functional groups such as Clinical Development, Clinical Development Operations, DMPK, Regulatory and other functions within Quality.

This person will support Stoke’s clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all Stoke clinical and bioanalytical studies. This person will be responsible for establishing Stokes inspections management program for GCP inspections and expected to be influential towards maturing Stoke’s quality culture and help reach a sustained state of inspection readiness. This person will establish and execute Stoke’s Clinical Quality Management Plan for compliance and risk monitoring for all Stoke clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GCP/GCLP guidelines and regulations and experience working with CROs and vendors. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to roll up their sleeves and directly contribute to the implementation of processes and resolution of issues as required. The person should have the capacity to apply QbD clinical development strategies and build and execute a risk-based quality management framework for ensuring data integrity and monitoring compliance. 

Key Responsibilities:

• Contribute to the development and maintenance of procedures for Stoke’s GCP/ GCLP managed activities.
• Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
• Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Participate in the development of GCP/GLP auditing strategies.
• Lead internal/external/Investigator site/TMF audits, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.
• Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Establish Stoke’s GCP inspection preparation program and facilitate mock PAI inspections as necessary.
• Co-Host GCP BIMO/Health Authority inspections, as necessary, and provide input to responses to regulatory agency findings and questions.
• Contribute to the development of Stoke’s Quality culture.

Required Skills & Experience:

• BS/BA, MS or PhD and a minimum of 15 years’ experience, respectively, in Biotech, Pharma or CRO.
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
• Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Conflict resolution/management and negotiation skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA.  This position is a hybrid position with an office setting based in our Bedford, MA location.

Travel:

This position will require approximately 10% travel.

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 Committee (DIB) underscores the importance of DIB to who we are and what we do. 

Benefits & Compensation:

At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.

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

For more information, visit stoketherapeutics.com or follow the company on X at @StokeTx.

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.