Primary Responsibilities:

• Serve as an integral member of the executive management team and contributing strongly to strategic and operational decision making, with high quality financial advice, experience and analysis.
• Act as a partner to the CEO and senior leadership team – appropriately debate and evaluate business and corporate development and financing strategies (including equity, debt and other non-dilutive funding).
• Be central to evaluating, organizing and implementing major transaction including IPO/other financings, working with the executive leadership team, Board of Directors, advisors/banks, IR and PR firms, and current and new investors.
• Facilitate investor and external relations; build relationships with and give presentations to analysts, investors and other audiences of relevance, working appropriately with the executive team and with advisers; act as a credible and effective representative of the company.
• Bring rounded commercial financial acumen to help the company to accurately build business cases, interpret performance and anticipate the impact of decisions, ensuring that financial input to business decisions is of the highest quality and provided on a timely basis.
• Ensure that the company identifies business issues before they escalate and assist the leadership team to timely interpret business performance and make financially informed business decisions.
• Build and maintain a small finance and accounting staff to provide timely, accurate financial records and ensure an appropriate internal control structure is maintained and documented.

Qualifications & Experience:

• Experience building and leading the finance organization in a biotech company that is based on high quality science and technology.
• Experience raising capital, familiarity with and understanding of public company accounting and reporting requirements (U.S. GAAP and Sarbanes-Oxley) and ideally has experience successfully taking a company through a US listing within the last 3 years.
• Evidence of a network with the relevant U.S. investor community members and advisors.
• Knowledge of the U.S. tax rules
• 10-15 years of experience in financial leadership roles including in small enterprises.
• Demonstrated proactive initiative taking and leadership qualities and have operated at Board level.
• Demonstrable strategic and commercial acumen, underpinned by robust financial, planning and analysis skills.
• Driven, energetic, with strong interpersonal skills, communication ability and powers of persuasion

Primary Location
Cambridge, MA and Bedford, MA

Interested candidates should submit a CV and cover letter via e-mail to careers@stoketherapeutics.com.

Primary Responsibilities:

• Preparing, recording, and processing of accounts payable and cash disbursements; interfacing with suppliers as needed.
• Preparing monthly General Ledger journal entries including payroll, depreciation, accruals, prepaid expenses, reclassifications, and other standard entries.
• Ensuring that project accounting is accurate.
• Reconciling various general ledger accounts with sub-systems.
• Maintaining all balance sheet reconciliations including cash and fixed assets.
• Preparing and analyzing monthly financial statements and general ledger, comparing budget to actual activity and observing trends.
• Active participation in the annual budgeting process.
• Preparing annual audit schedules and supporting and interfacing with auditors.
• Preparing annual tax schedules for tax accountants.
• Ensuring compliance with GAAP principles.
• Processing bimonthly payroll, including inputting employee maintenance, supporting various requests from Human Resources and external agencies. Other payroll activity as needed.
• Developing and documenting business processes and accounting policies to streamline accounting tasks and to maintain and strengthen internal controls.
• Assisting and owning tasks related to the implementation of processes pertaining to the newly implemented financial system.
• Performing ad-hoc analysis and troubleshooting of matters as they arise.

Minimum Qualifications:

• Bachelor’s degree in Accounting or Finance or related work experience.
• 5+ years of previous accounting experience.
• Fully understands GAAP and is able to articulate that information to others when needed.
• Ability to do research to find solutions for accounting issues.
• Experience working in the biotech industry.
• ERP Systems Software Experience a plus.

Skills/Competencies:

• Ideal candidate must be enthusiastic, self-motivated, results-oriented, and operate well in a team environment.
• Must be detail-oriented and possess good analytical and problem-solving skills.
• Excellent verbal and written communication skills and strong interpersonal skills.
• Ability to communicate effectively with the accounting team, executive management and all departments across the organization.
• Strong Microsoft Office and overall computer skills.
• Able to function independently; proactive, capable of finding solutions.
• Receptive to feedback, willing to learn, embrace continuous improvement, open and responsive to change.

Primary Location: Bedford, MA

Interested candidates should submit a CV and cover letter via e-mail to careers@stoketherapeutics.com.

Primary Responsibilities:

• Lead the drafting, review, negotiation and finalization of a broad range of agreements, including confidential disclosure, clinical trial, supply, quality, consulting, scientific advisor and master services agreements.
• Support the drafting, review, negotiation and finalization of financing and partnering agreements.
• Work with key internal R&D and corporate development stakeholders, outside vendors and outside legal counsel to ensure corporate agreements meet relevant timelines and business requirements.
• Utilize contract management system to track key contract information and generate reports as necessary.
• Maintain and update company agreement templates as needed.
• Provide training and guidance to employees regarding internal contract process, contract management system and related best practices.
• Support corporate governance filings within the finance department and executive team including quarterly and annual reports.
• Assist with Corporate Compliance and Risk functions by defining, reviewing and managing corporate policies.

Qualifications & Experience:

• Bachelor’s degree required.
• JD preferred from an accredited law school.
• Minimum 4 years’ experience as an attorney in a law firm representing biotech/pharma clients required.
• Minimum 4 years’ experience negotiating contracts in the biotech/pharma industry required.
• Demonstrated expertise in drafting and negotiating contracts to support pre-clinical and clinical studies.
• Experience drafting and negotiating legal language around financing & partnering transactions.
• Must be able to logically assess priorities and manage multiple timelines and projects.
• Ability to work both independently and collaboratively as needed to bring contracts to completion.
• Outstanding attention to detail required.
• Excellent analytical, organizational and project management skills.
• Strong written and verbal communication skills.
• Previous experience working in a fast-paced, deadline-driven environment.

Location: This position will be located primarily in Bedford, MA with occasional travel to the Cambridge, MA office.

Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.

Interested candidates should submit a resume and cover letter via e-mail to careers@stoketherapeutics.com.

Primary Responsibilities:

• Provide administrative support to senior management team members.
• Manage calendars for multiple management team members.
• Coordinate travel arrangements and provide expense reporting support.
• Provide reception support. Greet visitors, vendors and delivery personnel and direct them accordingly.
• Answer phone calls coming into the company’s main phone line. Direct callers as needed.
• Sort and distribute mail and packages.
• Arrange catering and logistics for company meetings and events.
• Assume responsibility for maintenance of office equipment, including computers, copy machines and fax machines.
• Maintain office supplies and other inventories.
• Additional projects as assigned.

Qualifications & Experience:

• High school diploma required.
• 3 + years of experience in an administrative role.
• Proficiency in MS Office with expertise in Microsoft Office, Word, PowerPoint and Excel.
• Detail-oriented and comfortable working in a fast-paced office environment.
• Exceptional communication skills.
• Superior organization skills and dedication to completing projects in a timely manner.
• Ability to maintain confidentiality.

Primary Location: This position is located in Bedford, MA with occasional travel to Cambridge, MA.

Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.

Interested candidates should submit a resume and cover letter via e-mail to careers@stoketherapeutics.com.

Primary Responsibilities:

In collaboration with the SVP, RA and QA, the Regulatory Operations and Project Management Director/Senior Director will:

• Collaborate with cross-functional teams to plan, create and submit original U.S. INDs and amendments, EU and Canadian CTAs and variations in eCTD format and ex-U.S. clinical trial applications in electronic or paper formats, as required (formatting, publishing, submitting, life-cycling and archiving sequences).
• Manage the technical aspects for submissions (e.g. eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation and transmission to regulatory health authorities).
• Serve as system owner for regulatory information tools and systems (e.g. eCTD publishing tools, electronic document management system (EDMS), library system and electronic templates).
• Develop SOPs for the regulatory information tools and systems and implement, validate and maintain accordance with applicable regulations.
• Maintain expert knowledge of electronic submission and computerized system validation standards.
• Identify potential risks to submission plans and propose risk mitigation strategies.
• Ensure tracking and archiving of regulatory communications and submissions.
• Support budgeting and forecasting for function and regulatory affairs department.
• Provide recommendations on resource needs for regulatory operations and records management activities, including the need for outsourcing (e.g. eCTD vendor, SPL vendor).
• Represent regulatory operations in project teams to support submission planning and ensure coordination of system development activities.
• Manage selection, implementation, validation (as applicable) and maintenance of IT tools for regulatory team.

Qualifications & Experience:

• Bachelor’s degree with a minimum of 12-15 years of experience in regulatory operations with demonstrated ability to present and articulate requirements.
• Direct experience filing INDs and NDAs; the ideal candidate will also have experience with filing CTAs in Europe and Canada.
• Detailed knowledge of eCTD publishing systems, EDMS technology and publishing software.
• Experience managing EDMS, regulatory publishing systems and tracking databases.
• Advanced user skills using MS Word, MS SharePoint, Adobe Acrobat Professional, eCTD content templates and experience with MS Excel, MS PowerPoint and MS Project or Smartsheet.
• Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications.
• Demonstrated experience and a clear understanding of submission content and format requirements.
• The ability to multitask, prioritize and work under pressure in adhering to deadlines.
• Solid experience administering and maintaining regulatory document authoring templates.
• Strong oral and written communication skills, as well as strong interpersonal skills.
• Strong project management and organizational skills.
• Ability to apply knowledge to new situations.

Candidates must be authorized to work in the U.S.

Compensation: Stoke offers a competitive compensation and benefit package.

Location: This position is based in the Cambridge, MA office. This role will also require regular travel to the Bedford, MA office location.

Interested candidates should submit a CV and cover letter via e-mail to careers@stoketherapeutics.com.

Primary Responsibilities:

• Lead all aspects of assigned clinical trial(s) (Natural History, Phase 1-3) and demonstrate a high level of knowledge of clinical operations, including methodologies, organization, project management and leadership capabilities.
• Actively participate in the development of department initiatives, including acting as lead on the development/definition of SOPs and processes.
• Utilize project management skills to ensure consistency in processes and drive clinical operations performance.
• Manage and oversee all study vendors (CROs) to ensure that Stoke’s clinical trials are getting the necessary resources and attention the vendor has committed to; ensure trial deliverables and performance goals are met and quality is maintained.
• Oversee the development of and adherence to clinical trial project timelines and ensure line function heads are informed of and understand risks/challenges; includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks.
• Author clinical study protocols, informed consent forms (ICFs) and other clinical documents.
• Coordinate the relevant and timely exchange of information/materials (e.g. subject enrollment, site selection/feasibility, and data collection) with other Stoke functions to support clinical trials delivery within the drug development process.
• Coordinate with CMC regarding drug forecasting and supply of drug products to sites.
• Support timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review/reconciliation efforts.
• Adhere to clinical trial budgeting process and provide input to finance on budget accruals and forecasts.
• Participate in clinical trial scenario planning (estimate time and cost).

Qualifications & Experience:

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with at least 3-5 years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO industry.
• Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs are required. Rare disease and neurology trial experience is highly desirable.
• Efficient in Microsoft Word, Excel, Outlook, PowerPoint and MS Project.
• Strong written and verbal communication skills.

Location: Cambridge, MA

Interested candidates should submit a CV and cover letter via e-mail to careers@stoketherapeutics.com.

Primary Responsibilities:

• Establishing internal oligonucleotide synthesis capability, including the set-up of new synthesis and purification equipment.
• Synthesis and purification of oligonucleotides from milligram to multigram scale.
• Synthesis of oligonucleotide conjugates and oligonucleotides containing novel chemistries.
• Sourcing of raw materials and all other reagents needed for oligonucleotide synthesis.
• Maintenance of all oligonucleotide synthesis and purification equipment.
• Recruiting and managing personnel to support oligonucleotide synthesis activities.
• Cross-training of other chemistry personnel in oligonucleotide synthesis and purification methodology.
• Interacting with external oligonucleotide synthesis CMOs to manage orders, assist with troubleshooting, and facilitate technology transfer as needed.
• Collaborating extensively with discovery and development project teams.

Qualifications & Experience:

• Ph.D. degree in chemistry or biochemistry with at least 10 years of post-graduate experience in oligonucleotide chemistry.
• Previous experience with ÄKTA Oligopilot and/or MerMade oligonucleotide synthesizer platforms.
• Previous experience with oligonucleotide conjugation chemistry.
• Strong organizational and recordkeeping skills.
• Strong presentational skills to be 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.

Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.

Location: Bedford, MA

Interested candidates should submit a CV and cover letter via e-mail to careers@stoketherapeutics.com.

Primary Responsibilities: 

• Characterization of oligonucleotides using LC-MS.
• Biophysical characterization of oligonucleotides, including T_m, viscosity, and protein binding.
• Formulation and distribution of oligonucleotides.
• Characterization of oligonucleotide formulations, including endotoxin and osmolality measurement.
• Physical and database management of internal compound inventory.
• Maintenance of the analytical lab and instrumentation.
• Working closely with other members of the chemistry team, and collaborate extensively with discovery and development project teams.

Qualifications & Experience:

• Bachelor’s or master’s degree in chemistry or biochemistry with 4+ years of relevant experience.
• Previous experience with LC-MS and other relevant analytical methodologies
• Ability to work as a team player in a dynamic environment.
• Strong organizational and record-keeping skills.
• Prior experience with oligonucleotides is ideal.

Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.

Location: Bedford, MA

Interested candidates should submit a CV and cover letter via e-mail to careers@stoketherapeutics.com.