Responsibilities include:

• 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.

Responsibilities include:

• Filing and supervising submission of multiple INDs and determining the strategy for multiple projects.
• Actively leading the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks and pathways for expedited development and timelines.
• Serving as the regulatory representative on project teams.
• Active involvement in writing/review of regulatory submissions.
• Interfacing with Health authorities.
• Coordinating all aspects of regulatory submissions.
• Proactively keeping updated on regulatory requirements and expedited approaches worldwide.
• Hiring, building, supervising and managing a team of regulatory professionals who will support Stoke’s efforts in multiple therapeutic areas.

Minimum Qualifications:

• Master’s degree is required, Pharm.D., Ph.D. or M.D. degree is preferred.
• At least 10 years of experience working in Regulatory Affairs; ideally in the biotech industry. Experience in rare diseases, oligonucleotides or neurology is required.
• Sound knowledge and experience in Regulatory Affairs and associated requirements, plus pharmaceutical industry experience in clinical trial and drug development work with a record of successful drug development through product approval in the U.S., E.U., Asia.
• Thorough knowledge of the drug development process including all expedited pathways and orphan drug designations, INDs, CTAs, NDAs and MAAs.
• Experience in interfacing directly with FDA and other Health authorities.

Skills/Competencies:

• Deep knowledge and understanding of global regulatory requirements and environment.
• Demonstrated strategic thinking and implementation in overall drug development.
• Must be able and willing to work diligently in a high-visibility, fast-paced environment and exhibit passion for patients with debilitating neurological diseases.
• Must be detail-oriented and possess good analytical and problem-solving skills.
• Excellent verbal and written communication skills and strong interpersonal skills.
• Ability to hire, manage and develop Regulatory staff members
• Results=focused and able to work under pressure and to set and meet deadlines.
• Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities.

Primary Location
Cambridge, MA and Bedford, MA

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

Responsibilities include:

• Act as senior strategic and operational leader for Clinical Operations providing a strong, clear voice both internally and externally.
• Serve as a key leader in the organization and work across the organization to provide clinical operations insights across the cross-functional teams.
• Build and manage/lead a clinical operations team.
• Direct the execution of clinical plans consistent with development strategy, corporate strategy and overall program objectives.
• Oversee the selection and management of all clinical vendors to ensure successful clinical trial implementation while adhering to FDA, EMEA, GCP, and ICH guidelines.
• Oversee the preparation of clinical documents, including protocols, IBs, clinical study reports, presentation of key clinical findings to internal and external constituents and clinical components of regulatory documents.
• Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future products.
• Ensure scientific and strategic integrity of all biostatistics deliverables.
• Employ innovative trial designs & statistical methodologies in the design of efficient and effective clinical trials while ensuring scientific and strategic integrity of deliverables.
• Oversee clinical operations activities (timelines, resource planning, budget/forecast and deliverables related to clinical development projects).
• Communicate clinical operations progress and issues to senior management and external parties as needed.
• Develop clinical operations quality systems, including SOP’s, document management, clinical operations personnel training and ensures departmental compliance with SOPs, GCP and regulatory requirements.
• Continue to evaluate new initiatives for the department to operate more efficiently including the development of new SOPs.
• Help build and maintain a highly-functional and efficient clinical operations organization including organizational roadmap, hiring/developing new team members, and shaping the organization’s culture around the world, including the assessment of new opportunities.

Basic Requirements:

• Requires a BA/BS, BSN, or related degree.
• Requires at least 15 years relevant clinical experience, with at least 5 years in clinical operations project management, ideally including rare disease experience.
• Technical expertise in and/or understanding of cross-function clinical trials processes from study start-up through study closure (e.g. clinical operations, data management, safety, biostatistics, medical writing).
• Experience building and leading a broad team of clinical operations specialists, ideally globally.
• Working, in-depth knowledge of industry standards including ICH guidelines, GCPs and the CFR.
• Strong leadership and management skills, excellent teamwork and collaboration skills.
• Direct knowledge of and experience in dealing with, and maintaining strong alliance relationships with, external alliance partners and vendors.

Preferred Requirements:

• Demonstrated, effective project management skills.
• Ability to assess complex issues and identify creative, practical solutions.
• Demonstrated success in meeting project timelines and budgets.
• Demonstrated success in identifying, negotiating and overseeing outsourced services and vendors.
• Ability to foster effective relationships with vendors, investigators, consultants and colleagues.
• Demonstrated ability to work independently, as well as in a team environment
• Excellent communication, writing and presentation skills.
• International experience a plus.

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

Responsibilities include:

• Aiding in developing the clinical strategy and integrated development plan for our Dravet Syndrome program and future programs in rare, orphan diseases, and working cross-functionally to implement, manage, interpret and communicate the results of clinical trials.
• Being responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, CSRs, annual IND reports, and clinical expert reports.
• Leading and supervising clinical trials, collaborating closely with the Clinical Operations team, and being accountable for all deliverables of clinical trials under his/her direct responsibility.
• Responsible for analyzing clinical data, including safety monitoring in collaboration with PV.
• Developing and maintaining relationships with key opinion leaders and PIs.
• Organizing and presenting at relevant clinical advisory boards, DMCs and medical/scientific meetings.
• Writing manuscripts, publications, or other documents intended for external audiences.
• Helping to ensure Clinical Study Team compliance with FDA, EMA, PMDA, ICH and GCP guidelines and internal SOPs.
• Contributing in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates.
• Traveling, as needed, nationally and internationally.

Qualifications & Experience:

• M.D. or M.D./Ph.D. required.
• Board certified or eligible in a medical or pediatric subspecialty preferred.
• Expertise in neurology or orphan diseases preferred.
• Strong record of basic and/or translational research productivity.
• At least 2 years of early clinical development experience in an industry setting. Substantial experience working on industry-sponsored trials will be considered.
• Experience with oligonucleotide therapeutics is an advantage.
• Experience with design, execution, and analysis of Phase 1-2a clinical studies.
• Thorough understanding of Phase I-III drug development with proven ability to plan and conduct clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents.
• Excellent written and verbal communication skills to meet the needs of varied audiences.  Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
• Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.
• Excellent analytical, problem-solving and strategic planning skills.
• Well organized with strong management, leadership, mentoring and motivational skills.
• Ability to work independently and thrive in a fast-paced environment.
• Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients.

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

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

Responsibilities include:

• 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.
• 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.

Responsibilities include:

• 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.

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

Responsibilities include:

• Characterization of oligonucleotides and development of LC-MS and HELISA based bioanalytical methods and sample testing as well as data interpretation and reporting to support research and non-clinical studies.
• Transferring methods to CROs and managing their work.
• Supporting development initiatives, including immunohistochemistry and biomarker method (LC-MS/MS, ELISA, MSD etc.) development.
• Maintaining the bioanalytical lab and keeping the instruments running properly.

Qualifications & Experience:

• Ph.D. with 4-6 years of academic or industry experience in a relevant field.
• In-depth knowledge of bioanalytical chemistry and techniques including HPLC, mass spectrometry (MS/MS) and ligand binding assays.
• Strong hands-on LC-MS instrumentation skills and the ability to independently develop, implement, and execute bioanalytical LC-MS based assays.
• Excellent problem-solving skills and the ability to work as a team player in a dynamic environment.
• Drug development experience particularly in nucleic acid therapeutics is highly desirable.
• Prior experience in quantitation of oligonucleotides in biological matrices is ideal.

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

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

Responsibilities include: 

• 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.

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

Responsibilities include:

• Working closely with project and pharmacology team members to plan and perform in vivo samples.
• Performing tissue dissection and collection.
• Processing and analyzing in vivo samples.
• Capturing and presenting data in reports and team meetings.
• Assistance with coordination of studies and sample processing at contract research organizations.
• Exploration and development of new in vivo techniques and models.
• Working closely with animal facility management staff to oversee operations.
• Assistance in IACUC document preparation and renewals.

Qualifications & Experience:

• Bachelor’s or master’s degree in biomedical-related field is required.
• Mouse handling, test article administration (particularly to CNS and/or eye), surgery and tissue dissection skills are required.
• Excellence in record keeping, laboratory organization and communication skills is required.
• Familiarity with IACUC protocols and policies is required.
• Flexibility and willingness to learn new techniques is required.
• Experience in neuroscience or ocular research is a plus.
• Experience interacting with contract research organizations is a plus.
• Experience working with oligonucleotides is a plus.

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

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

Responsibilities include:

• Designing, executing, troubleshooting research efforts using techniques such as cell-based assays, RT-PCR, Taqman qPCR, and Western blot.
• Independent exploratory assay development.
• Working collaboratively with team members to address complex scientific / technical challenges.
• Interpreting and communicating relevant research results and conclusions to internal and external stakeholders.
• Contributing to and independently suggesting new project concepts.
• Authoring preclinical reports and first drafts of publications with some assistance.
• On occasion, supporting the drafting of IND sections for regulatory filings with minimal supervision.
• Maintaining accurate documentation of experiments.
• Keeping current on a broad range of literature relevant to function.
• Training junior associates.

Qualifications & Experience:

• Scientist: Bachelor’s or master’s degree with 10 years of post-graduate experience, or Ph.D.
• Senior Scientist: Ph.D. with 4+ years of postdoctoral training or industry experience.
• Expertise in RNA techniques and cell-based assays, target discovery and RNA metabolism.
• A record of peer reviewed publications.
• Strong problem-solving skills in addition to good oral and written communication skills.

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

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