Associate Director, Clinical Quality Compliance

Role: Associate Director of Clinical Quality Compliance, serving as a primary GCP and GCLP compliance lead to support Stoke's clinical development efforts. Responsibilities: develop and maintain GCP/GCLP procedures, support clinical study execution ensuring regulatory adherence, establish risk-based quality management plans, lead audits and inspections, investigate scientific misconduct, and foster a culture of quality. Requirements: BS/BA, MS, or PhD with 8+ years in biotech, pharma, or CRO; strong knowledge of FDA, EU, ICH GCP/GCLP regulations; proficient in auditing, risk assessment, and regulatory interactions; effective in cross-functional collaboration and managing multiple projects. Preferred: experience in CNS or ophthalmology therapeutic areas, clinical operations, or quality assurance in early or late-phase clinical trials. HighValue: focus on CNS and eye diseases, antisense oligonucleotide modalities, GCP/GCLP compliance, clinical audit and inspection readiness, and cross-functional interface across clinical development, regulatory, and quality teams. WorkSetup: hybrid in Bedford, MA, later relocating to Waltham, MA; approximately 10% travel.