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Stoke Therapeutics · 2 months ago

Executive Director, Clinical Development Operations Excellence and Compliance

Bedford, MA

Full-time

Onsite

Director/Executive

$286K/yr - $322K/yr

18+ years exp

Stoke Therapeutics is a biotechnology company focused on restoring protein expression through RNA medicine. The Executive Director, Clinical Development Operations Excellence and Compliance, is responsible for enhancing the efficiency, quality, and compliance of clinical development operations, driving operational excellence and continuous improvement across clinical programs.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Growth Opportunities

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

Qualification

Clinical Development OperationsGlobal clinical research regulationsOperational excellenceInspection readinessAudit managementStakeholder managementCross-functional alignmentLeadership skillsCommunication skills

Required

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