Senior Director, Clinical Quality Compliance
Stoke Therapeutics
9 hours ago
Remote friendly (Bedford, MA)
United States
Clinical Research and Development
Position Purpose:
Sr. Director, Clinical Quality Compliance will oversee all aspects of GCP and GCLP for Clinical Trials sponsored by Stoke; embed GCP quality considerations into clinical development; lead clinical quality strategy across Stoke’s clinical programs; drive proactive risk identification/mitigation to ensure inspection readiness and effective regulatory engagement; establish and execute Stoke’s BIMO inspection readiness program; oversee development/execution of Stoke’s Clinical Quality Management Plan; contribute to a scalable Quality Management System always ready for inspection.
Key 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 to define, develop, and operationalize SOPs and support implementation and regulatory compliance.
- Partner with Quality Systems to maintain a fit-for-purpose eQMS and standardize processes for GxP compliance management.
- Provide quality oversight and compliance support across non-clinical, clinical, and safety programs, including strategic quality oversight plans and participation in study teams.
- Develop and oversee integrated, data-driven, risk-based quality management plans to monitor compliance health.
- 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 supportive services for timely regulatory submissions.
- Establish GCP inspection preparation program and facilitate mock PAI inspections as necessary.
- Host GCP BIMO/Health Authority inspections and contribute to responses to regulatory findings/questions.
- Contribute to Stoke’s quality culture.
- Partner with Regulatory Affairs to align quality with regulatory strategy.
- Lead, mentor, and develop a small team of quality professionals.
Required Skills & Experience:
- BS/BA, MS, or PhD with at least 15 years’ experience in Biotech, Pharma, or CRO.
- Working knowledge of relevant FDA, EU, ICH GCP/GCLP regulations and guidelines.
- Proven ability to set high standards for performance and accountability.
- Demonstrated adaptability and calculated risk-taking; resilience through change.
- Ability to foster transparent, 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.
Compensation & Benefits:
- Anticipated salary range: $265,000–$290,000; final offer based on scope/experience/qualifications/education/market benchmarks/internal equity/geography.
- Annual bonus and equity participation.
- Medical, dental, and vision insurance; life, long- and short-term disability insurance; paid parental leave; 401(k) with company match; unlimited vacation time; tuition assistance; Employee Stock Purchase Program (ESPP).
Application Instructions:
- Apply directly to the position listed on Stoke’s Career Center: https://www.stoketherapeutics.com/careers/
Sr. Director, Clinical Quality Compliance will oversee all aspects of GCP and GCLP for Clinical Trials sponsored by Stoke; embed GCP quality considerations into clinical development; lead clinical quality strategy across Stoke’s clinical programs; drive proactive risk identification/mitigation to ensure inspection readiness and effective regulatory engagement; establish and execute Stoke’s BIMO inspection readiness program; oversee development/execution of Stoke’s Clinical Quality Management Plan; contribute to a scalable Quality Management System always ready for inspection.
Key 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 to define, develop, and operationalize SOPs and support implementation and regulatory compliance.
- Partner with Quality Systems to maintain a fit-for-purpose eQMS and standardize processes for GxP compliance management.
- Provide quality oversight and compliance support across non-clinical, clinical, and safety programs, including strategic quality oversight plans and participation in study teams.
- Develop and oversee integrated, data-driven, risk-based quality management plans to monitor compliance health.
- 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 supportive services for timely regulatory submissions.
- Establish GCP inspection preparation program and facilitate mock PAI inspections as necessary.
- Host GCP BIMO/Health Authority inspections and contribute to responses to regulatory findings/questions.
- Contribute to Stoke’s quality culture.
- Partner with Regulatory Affairs to align quality with regulatory strategy.
- Lead, mentor, and develop a small team of quality professionals.
Required Skills & Experience:
- BS/BA, MS, or PhD with at least 15 years’ experience in Biotech, Pharma, or CRO.
- Working knowledge of relevant FDA, EU, ICH GCP/GCLP regulations and guidelines.
- Proven ability to set high standards for performance and accountability.
- Demonstrated adaptability and calculated risk-taking; resilience through change.
- Ability to foster transparent, 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.
Compensation & Benefits:
- Anticipated salary range: $265,000–$290,000; final offer based on scope/experience/qualifications/education/market benchmarks/internal equity/geography.
- Annual bonus and equity participation.
- Medical, dental, and vision insurance; life, long- and short-term disability insurance; paid parental leave; 401(k) with company match; unlimited vacation time; tuition assistance; Employee Stock Purchase Program (ESPP).
Application Instructions:
- Apply directly to the position listed on Stoke’s Career Center: https://www.stoketherapeutics.com/careers/