Join Our Team
At Stoke, we are building a team of talented scientists, experienced drug developers and insightful leaders to address severe genetic diseases.
We are excited about breaking new scientific ground. This work is challenging, but we know we have the team to do it. We’re united around a common goal: to improve the lives of people living with severe genetic diseases.
Current openings
Stoke is always looking for individuals with a passion for developing precision medicines to tackle severe genetic diseases. For more info, please contact careers@stoketherapeutics.com.
Associate Director/Director, Clinical Data Management
Stoke Therapeutics is seeking a highly motivated and enthusiastic data management professional with hands-on expertise in clinical data management. The Associate Director/Director will be responsible for leading data management activities for one or more development programs and will serve as the highest point of escalation within data management per assigned programs(s). This role will report to the VP of Clinical Operations 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.
Primary Responsibilities:
- Account 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 products/programs, consisting of multiple clinical studies.
- Establish over time and maintain 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 SOPs and standards for data management to support Stoke’s development programs.
- Develop the Data Management Plan (DMP) across programs and maintain throughout life cycle 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 coordinate UAT of eCRF build and validation documents, included but not limited to editing documents, developing issue logs and creating the 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, including but not limited to data reconciliation and/or coding.
- Accountable for eDiary, PRO and other electronic data collection on portable devices 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 DBs.
- Coordinate and communicate with DB vendors on a consistent basis to address Stoke’s clinical team’s requests, project plans and/or eCRF development activities.
- Participate in the preparation and presentation of data, when applicable.
- Ensure data system compliance by following the established guidelines of national and international regulatory authorities.
- Help to identify and troubleshoot operational problems, issues, obstacles and barriers for studies and programs; work with appropriate teams towards action and ensure resolution.
Qualifications & Experience:
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred, with at least 5-10 years of progressive experience in data management within the biotech, pharmaceutical or CRO industry. 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, CDASH/SDTM standards, medical terminology, medical coding dictionaries and quality control processes.
- Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management.
- 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.
Computer Skills:
- Microsoft applications (Outlook, Word, Excel, PowerPoint, Project).
- In-depth knowledge of clinical data management systems (e.g. Medidata Rave) required.
- SAS Viewer and other data visualization tools (Elluminate, Spotfire).
Interested candidates should submit a CV and cover letter via email to careers@stoketherapeutics.com.
Research Associate/Senior Research Associate, Biology
Stoke is seeking to hire a Research Associate or Senior Research Associate with a strong background in molecular and cell biology research. The successful candidate will work in a fast-paced and dynamic environment with a team of scientists and research associates to identify oligonucleotide-based drug candidates for the treatment of ocular and CNS diseases.
Primary Responsibilities:
- Work at the bench to support ongoing research efforts in screening and evaluating oligonucleotide-based drug candidates for ocular and CNS diseases.
- Perform cell and molecular biology techniques, including cell culture of primary cell lines, transfection, nucleofection, RNA preparation, primer design, qPCR, RT-PCR, western blotting and other project-specific assays, as necessary.
- Interpret experimental data and play an active role in assay development and planning of further experiments.
- Maintain accurate documentation of experiments in electronic lab notebooks (ELN).
- Present research findings at weekly group meetings and occasional company-wide and external meetings, as necessary.
- Work independently as well as collaborate with peers in a results-oriented research environment.
Qualifications & Experience:
- B.S/M.S. with a minimum of 3 years post-graduate experience in molecular and cell biology research, preferably in industry.
- Strong hands-on experience in RNA isolation techniques, mammalian cell culture and cell-based assays is a must.
- Prior drug development experience for CNS and/or ocular diseases is desirable, but not required.
- Experience in antisense-based target validation and mouse handling is a plus.
- Strong organizational and record-keeping skills, experience using electronic lab notebooks (ELN) is highly desirable.
- Strong analytical and presentational skills to be able to interpret and communicate experimental results in group and company-wide meetings.
Primary Location: Bedford, MA
Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.
Interested candidates should submit a CV and cover letter via email to careers@stoketherapeutics.com.