Director, Clinical Data Management

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 Director of Clinical Data Management will be responsible for leading data management activities for one or more development programs and serves as the highest point of escalation within Data Management per assigned programs(s). This role will report to the Executive Director, Clinical Data Management and be accountable for managing day-to-day operations of data management activities. The candidate will be responsible for oversight of Contract Research Organization (CRO) activities related to data management, including project management, vendor management, and coordination of internal reviews. Consistent with ICH E6(R3), the role champions a risk-based, quality-by-design approach to data management and data governance across the portfolio.

Key Responsibilities:

Accountable for data management activities for Stoke clinical studies and oversee CRO data management activities that support ongoing clinical programs.

Oversee data management activities for one or more product/programs, consisting of multiple clinical studies

Manage a best in class Data Management team, consisting of highly qualified and experienced data managers

Balance resources, and ensure appropriate levels to support organization activities (current and future)

Manage budgets and expenses, including budget projections

Support inspection readiness, quality compliance, and training initiatives pertaining to Data Management activities

Create SOP’s and standards for Data Management to support Stoke’s development programs

Develop the Data Management Plan (DMP) across programs and maintain throughout lifecycle of study project to ensure DMP is followed according to study design and requirements.

Review clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis).

Review DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.

Review Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.

Reconcile electronic data transfers from vendor to Sponsor.

Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.

Maintain/track EDC user management and other Clinical databases across allocated Clinical trials.

Ensure clinical data within EDC is of high quality to support lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.

Accountable for eCOA (eDiary/ePRO/ClinRO/ObsRO), wearable and sensor data, and other electronic data collection methods to make sure the design of data collection meets the scientific objective.

Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.

Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.

Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB.

Coordinate and communicate with DB vendors on consistent basis to address. Clinical team’s requests, project plans, and/or eCRF development activities.

Participates in the preparation and presentation of data, when applicable.

Ensure data system compliance by following the established guidelines of national and international regulatory authorities. Helps to identify and troubleshoot operational problems, issues, obstacles, and barriers for studies and programs; Working with appropriate teams towards action and ensuring resolution

Establish and oversee a risk-based quality management (RBQM) approach to clinical data, including the definition and ongoing monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) in line with ICH E6(R3).

Drive data-driven oversight through centralized monitoring, data analytics, and review dashboards/metrics (e.g., Spotfire, Power BI, J-Review) to detect anomalies, outliers, and trends across studies.

Ensure data integrity and 21 CFR Part 11 compliance across EDC and external data sources, applying ALCOA+ principles and current computer system validation/assurance (CSV/CSA) expectations.

Promote standardization and automation (e.g., SAS, R, or Python) and evaluate emerging AI/ML-enabled tooling to improve the efficiency, consistency, and quality of data review and reporting

Required Skills & Experience:

Bachelor’s degree or higher in a scientific or healthcare discipline (advanced degree a plus), with 10+ years of progressive experience in data management within biotech, pharmaceutical, or CRO settings, including prior line-management / people leadership experience. Rare Disease and Neurology trial experience are highly desirable.

Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in the pharmaceutical industry

Experience working in an outsourced data management model

Knowledge of and experience with EDC databases CDISC standards (CDASH, SDTM and ADaM, including Define-XML), medical terminology, medical coding dictionaries (MedDRA, WHODrug), and quality control processes

Working knowledge of GCP E6(R3), 21 CFR Part 11 and applicable FDA/EMA requirements, including risk-based quality management and data integrity (ALCOA+) principles

Prior experience filing a BLA or NDA preferred

Ability to manage multiple initiatives and shifting priorities within a small company environment.

Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.

Strong experience in early phase drug development and rare diseases required

Microsoft Applications (Outlook, Word, Excel, PowerPoint, Project, Visio)

In depth knowledge of clinical data management systems (eg: Medidata Rave Veeva Vault CDMS) required; working familiarity with data review, visualization, and analytics tools (e.g., SAS, R/Python, Spotfire, Power BI, J-Review, or elluminate)

Location(s):

This position is open to both hybrid and remote work arrangements. Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026.

Travel:

This position will require approximately 5% 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 $225,000 - $244,000. 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.

Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:

https://www.stoketherapeutics.com/careers/

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.