Join Our Team

Responsibilities:

• Research and gather information to be used in the planning, preparation, and submission of external reporting-related SEC filings.
• Ensure preparation and timely filing of Form 10-Q/10-K/8-K in accordance with U.S. GAAP and SEC requirements using ActiveDisclosure.
• Research technical accounting matters and author technical accounting memoranda regarding changes in or application of guidance and treatment of transactions.
• Actively participate in quarterly reviews and annual audits.
• Manage and actively participate in the annual budgeting process and interim forecasting process.
• Responsible for the monthly variance analysis process and reviewing results with Department Managers.
• Identify and implement budgeting software to aid in the preparation of the annual budget and forecasts.
• Collaborate to build and maintain models related to revenue, budgeting and forecasting.
• Responsible for monthly and quarterly accruals related to clinical trials and outside research agreements.
• Assist in the preparation of clinical trial budgets and tracking of expenses.
• Assist with special projects as needed.

Qualifications:

• Bachelor’s degree in either Accounting or Finance required.
• CPA or CPA candidate strongly preferred.
• Between 3-5 years of public accounting/public company experience and/or SEC reporting experience required.
• Proficient with the conceptual and practical application of U.S. GAAP.
• Working knowledge of financial reports and disclosures required.
• Working knowledge of SEC reporting requirements preferred.

Preferred Skills and Experience:

• Experience with Active Disclosure and NetSuite and/or a willingness to learn.
• Biotech/pharmaceutical industry experience preferred.
• Proficient with Microsoft Office (e.g., Outlook, Word, Excel and PowerPoint).
• Excellent written and oral communication skills.
• Strong attention to detail and accuracy.
• Strong financial modelling skills.
• Strong analytical skills.
• Self-motivated; able to work both independently to complete tasks and respond to requests and with others to utilize their resources and knowledge to identify quality solutions.
• Strong organization, planning, and project management skills; ability to prioritize tasks for self and team to meet requirements and deadlines.
• Deliver an accurate, consistent and timely work product in accordance with established deadlines and policies.

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Stoke is seeking an enthusiastic and highly motivated scientist to join the bioanalytical, DMPK and biomarker group. The successful candidate will be responsible for:

• Responsible for leading the scientific, technical and operational efforts of the DMPK for early development projects.
• Design, conduct and interpret in vitro ADME/DMPK and bioanalytical findings, write reports, and communicate with scientists. When needed, submit the studies to CROs and monitor the work.
• Responsible for working with internal teams and various CROs to support PK, PK/PD and toxicology studies.

Qualifications & Experience:

• Ph.D. in pharmaceutical sciences or related field with minimum 4 to 9 years of experience including industry experience in relevant field.
• In depth knowledge of bioanalytical chemistry and techniques including HPLC, mass spectrometry and ligand binding assays.
• Prior experience in monitoring and managing external work at CROs is required.
• The position requires sound knowledge of ADME-PK, modeling techniques and tools (e.g. WinNonLin/Phoenix) as well as pharmacokinetics, compartmental and non-compartmental analysis.
• The candidate should have demonstrated experience in writing regulatory summary documents.
• Strong organization, multi-tasking and communication skills are key attributes of the successful candidate.
• Excellent problem-solving skills and ability to work as a team player in a dynamic environment.
• Drug development experience particularly in nucleic acid therapeutics and quantitation of oligonucleotides in biological matrices is highly desirable.

Location: Bedford

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Stoke is seeking an enthusiastic and highly motivated pharmacologist to join the preclinical development group. The successful candidate will be responsible for:

• Evaluating new targets via Stoke Platform technology
• Helping to establish internal in vitro pharmacology capabilities, including the use of a broad array of tissue culture models and assays for target evaluation
• Developing assay systems to evaluate the functional impact of Stoke ASOs
• Building new in vitro capabilities to support project goals
• Managing an Associate & cross-training other scientists
• Interacting with external academic and CROs and facilitating technology transfer as needed
• Collaborating extensively with discovery and other development project team members

Qualifications & Experience:

• Ph.D. degree in molecular/cell biology or biochemistry with at least 4 years of post-graduate experience in developing assay systems for drug development
• Previous experience with CNS and/or ocular drug development is a must
• Previous experience with complex cell system assays e.g. iPSCs, 3D culture systems, organoids and other ex vivo culture systems
• Deep knowledge of biological pathways and assay development
• Strong organizational and recordkeeping skills
• Strong presentation skills, able to communicate to both internal and external audiences
• Ability to work as a team player in a dynamic environment
• Ability to lead from the bench

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This position will oversee all medicinal chemistry activities from Hit identification to clinical proof-of-concept. This position is responsible for creating and executing a chemistry strategy to support both discovery and early development activities, including the identification of key areas for investment, building appropriate internal and external capabilities, and communicating the company’s chemistry strategy both internally and to the external scientific community.

Duties & Responsibilities:

Specific duties and responsibilities include, but are not limited to:

• Create and execute overall chemistry plan to ensure robust, cost-effective support of company discovery and development portfolio
• Recruit high-quality chemistry personnel to support chemistry plan
• Oversee design and manufacture of oligonucleotides to support all stages of discovery and lead optimization for preclinical programs
• Evaluate and select CROs and CMOs to support key preclinical chemistry activities
• Oversee both internal chemistry team and external preclinical chemistry resources
• Oversee CMC activities for all preclinical programs
• Assist in authoring of CMC sections of regulatory submissions
• Regularly assess developments in the field of oligonucleotide therapeutics and identify areas for future investment
• Communicate chemistry strategy and activities to senior management and Board of Directors on regular basis
• Serve as primary liaison with corporate partners on all issues related to medicinal chemistry
• Present updates of Stoke platform and chemistry developments at key scientific conferences
• Willingness to live and work in Boston area
• Occasional travel for oversight of external CROs is expected

Required Qualifications & Experience:

• A Ph.D. in organic chemistry or medicinal chemistry or related discipline
• At least 15 years of industry experience, including at least 10 years in oligonucleotide therapeutics
• Demonstrated success in the design, medicinal chemical optimization, and formulation/delivery of oligonucleotide therapeutics
• Previous experience in the GMP manufacture of oligonucleotide therapeutics, either directly or through a contract manufacturer, is a plus
• Previous experience authoring CMC sections of regulatory submissions is a plus
• Proven experience managing multiple direct reports
• Strong presentation skills to facilitate communication with both internal and external audiences
• Strong decision-making skills to facilitate execution of timelines
• Ability to work as a team player

Location: Bedford & Cambridge

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Stoke is seeking an enthusiastic and highly motivated Vice President of Human Resources to lead the Stoke Therapeutics Human Resource function. The successful candidate will be an active member of the Executive Team reporting directly to the CEO and will also be responsible for working closely with the Board of Directors and Compensation Committee. The successful candidate will possess a strong background in strategic hiring and selection, designing and implementing organizational structures, organizational and employee professional development, compensation strategy and total rewards programs.

Responsibilities:

• Partner with the executive team and senior management to align the organizational structure, practices, policies, and communication with the company’s strategy and culture.
• Evaluate and advise on the impact of strategic planning and growth initiatives on attracting, motivating, developing and retaining employees.
• Provide human resources technical advice, knowledge and leadership to others within the human resources group and the overall organization.
• Anticipate organizational issues and proactively provide practical recommendations of action.
• Lead the development and oversee the implementation of Stoke’s compensation philosophy and structure.
• Develop progressive and proactive compensation and benefits programs to motivate, incentivize and reward employees in a manner that fosters high performance and engagement.
• Create and implement programs to enhance organizational and employee development plans, including training programs, performance management systems and reward and recognition tools.
• Design and implement talent management programs including talent reviews and succession planning and the associated action plans.
• Manage and facilitate Stoke’s performance management process; ensure effective management and setting of goals throughout the organization appropriately tied to corporate goals and employee performance.
• Identify and help managers foster management practices that lead to outstanding performance for individuals and teams.
• Develop and oversee staffing and recruiting plans and efforts to identify and recruit top talent within and outside the company.
• Develop organizational plans that include organizational structure, job design and personnel forecasting.
• Oversee the development of human resources operations, systems and processes that will scale to support the organization as the company continues to grow and improve the overall operation and effectiveness of the company.
• Ensure that policies and procedures are consistently and equitably applied and that appropriate legal and compliance requirements are met while providing a proactive, positive employee relations climate.
• Provide leadership in interactions with the Compensation Committee of the Board of Directors, including coordinating with the Committee’s external compensation consultant, and partnering with the General Counsel and CFO to support analyses for and advice to the Compensation Committee.
• Partner with the Legal and Finance functions to insure HR processes and systems meet local, state, federal and corporate compliance requirements.

Qualifications & Experience:

• Undergraduate degree required, advanced degree strongly preferred with 15+ years of experience in human resources.
• Minimum 3 years’ experience as the top HR executive in a small to mid-sized company, or an independent division of a large company(preferably in biotech).
• Experience working with all levels of the organization, including a Board of Directors.
• Previous experience working in the pharmaceutical, biotechnology or life sciences industries is strongly preferred. In depth human resources experience working in staffing, compensation, benefits and training & development is highly desired.

Location: Bedford & Cambridge

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Stoke is seeking an enthusiastic and highly motivated pharmacologist to join the preclinical development group.

Primary Responsibilities:

• Establish internal in vitro pharmacology capabilities, including the use of a broad array of tissue culture models and assays for target evaluation.
• Develop assay systems to evaluate the functional impact of Stoke ASOs.
• Build new in vitro capabilities to support project goals.
• Manage a small team of scientists & cross-training of other scientists.
• Recruit personnel to support preclinical development of a growing pipeline.
• Manage and interact with external academic and CROs and facilitate technology transfer as needed.
• Collaborate extensively with discovery and other development project team members.

Qualifications & Experience: 

• Ph.D. degree in molecular/cell biology or biochemistry with at least 9 years of post-graduate experience in developing assay systems for drug development.
• Previous experience with CNS and/or ocular drug development is a must.
• Previous experience with complex cell system assays e.g. iPSCs, 3D culture systems, organoids and other ex vivo culture systems.
• Deep knowledge of biological pathways and assay development.
• Previous experience managing teams.
• Strong organizational and record keeping skills.
• Strong presentation skills. Able to communicate to both internal and external audiences.
• Ability to work as a team player in a dynamic environment.
• Ability to lead from the bench.

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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).

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