Senior Director, Clinical Quality Compliance

Stoke Therapeutics • Bedford, MA

14d • $265,000 - $290,000 • Hybrid

About The Position

The Sr. Director, Clinical Quality Compliance, will be responsible for overseeing all aspects of GCP and GCLP associated with the development, maintenance and oversight of activities related to Clinical Trials sponsored by Stoke. This role will report into The VP of Quality and will partner closely with other cross-functional groups such as Clinical Development, Clinical Development Operations, DMPK, Toxicology, Regulatory and other functions within Quality to embed GCP quality considerations into clinical development.
This person will lead clinical quality strategy across Stoke’s clinical programs. This role ensures global GCP and GCLP compliance (e.g., FDA, EMA, ICH etc.), provides guidance on clinical trial operations, and fosters a culture of quality, compliance, and patient safety. The Senior Director is expected to drive proactive risk identification and mitigation across the clinical development lifecycle, ensuring inspection readiness and effective regulatory engagement. This person will be responsible for establishing Stokes BIMO inspections readiness program and is expected to influence Stoke’s quality culture and help reach a sustained state of inspection readiness. This person will oversee the development and execution of 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.
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 an RBQM framework for ensuring data integrity, patient safety and monitoring compliance.

Requirements

• BS/BA, MS or PhD and a minimum of 15 years’ experience, in Biotech, Pharma or CRO
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines
• Proven capacity to set high standards for performance and accountability, ensuring clarity of expectations and outcomes
• Demonstrated ability to encourage adaptability and calculated risk-taking, modeling resilience through change
• Ability to foster transparent, courageous communication and cross-functional collaboration
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment
• Conflict resolution/management and negotiation skills
• Excellent organizational, interpersonal, verbal, and written communication skills

Responsibilities

• Lead clinical quality strategy and execution across clinical programs to ensure compliance with Stoke SOPs and FDA, EMA, and other global regulations.
• Collaborate with Functional Leaders, Business Process Owners (BPOs), and Clinical Development Operations departments to define, develop, and operationalize SOPs, support implementation, and ensure regulatory compliance
• Partner with Quality Systems to maintain a fit for purpose eQMS and standardize processes as applicable for GxP compliance management
• Provide quality oversight and compliance support across non-clinical, clinical, and safety programs, including development of strategic quality oversight plans and participation in study teams
• Develop and oversee the execution and interpretation of integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Support CRO and vendor selection, qualification and oversight, including establishment of Quality Agreements
• Support investigations into scientific misconduct and/or serious breach of GCP
• 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
• 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
• Partner with Regulatory Affairs to align quality with regulatory strategy
• Lead, mentor, and develop a small team of quality professionals

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree