Associate Director, Clinical Quality Compliance

Stoke Therapeutics; Bedford (MA); Hybrid; USD 192,000 - 215,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

401K with company match

Unlimited vacation

Tuition assistance

Employee Stock Purchase Program (ESPP)

Job summary

Stoke Therapeutics, headquartered in Bedford, MA, seeks an Associate Director of Clinical Quality Compliance to oversee GCP/GCLP compliance across clinical studies. This role reports to the VP of Quality and collaborates with Clinical Development, Regulatory, and others to ensure regulatory readiness.

The role emphasizes developing quality management systems, risk-based plans, audits, and investigating deviations while maintaining a culture of inspection readiness. Hybrid work in MA with travel.

Qualifications

• BS/BA, MS or PhD with 8+ years in Biotech, Pharma or CRO
• Working knowledge of FDA/EU/ICH GCP and GCLP regulations/guidelines
• Proficient auditing skills with objective evidence and clear findings
• Ability to work autonomously and deliver results on time
• Collaborate effectively in a cross-functional matrix environment
• Strong conflict resolution and negotiation skills
• Ability to manage multiple projects in a fast-paced environment
• Excellent organizational and written communication skills

Responsibilities

• Develop and maintain procedures for GCP/GCLP activities
• Support compliant execution of clinical studies to meet regulatory requirements
• Create data-driven risk-based quality management plans
• Develop GCP/GLP auditing strategies
• Lead internal/external/site audits and drive CAPAs
• Investigate scientific misconduct and regulatory breaches and report findings
• Provide GCP compliance interpretation and training
• Prepare inspection readiness programs and mock inspections
• Support regulatory responses to findings
• Contribute to Stoke's quality culture

Skills

GCP/GCLP knowledge

Auditing

Regulatory interpretation

Cross-functional collaboration

Time management

Communication (oral & written)

Project management

Negotiation/Conflict resolution

Education

BS/BA, MS or PhD

Job description

About Stoke

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, 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’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

About Stoke

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, 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’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose

The Associate Director, Clinical Quality Compliance will be a 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 contribute to 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.

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 8+ 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 is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position currently based in Bedford and will later be based in Waltham.

Travel

This position will require approximately 10% travel.

Compensation & Benefits

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $192,000 - $215,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

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).

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

For more information, visit https://www.stoketherapeutics.com/.

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.