Join Our Team

Stoke is seeking a highly motivated Program Leader to join a company pioneering genetic disease treatments. This Director level position is responsible for providing expertise and leadership in a preclinical program for Autosomal Dominant Optic Atrophy (ADOA) and additional preclinical programs as appropriate. The program Leader will work closely with the Senior Program Manager, Chief Scientific Officer (CSO) and Chief Medical Officer (CMO) to develop and manage the integrated development plan. This position will report into the Chief Scientific Officer.

Key Responsibilities:

• The candidate will lead the cross-functional drug development team through preclinical phases to support Stoke Therapeutic’s ADOA program to ensure delivery of a high-quality efficacy and safety package for development.
• Provide direction and leadership to the ADOA program team including setting strategy, scientific oversight of activities, data review based on key milestones, budget, and planning.
• Proactively identifies challenges, risks, and prepares team with mitigations to navigate team through technical and program challenges as they arise.
• Work closely with the Senior Program Manager to determine program goals, priorities, resource requirements, budget, and timelines.
• Collaborate with discovery, DMPK, Toxicology, Chemistry/CMC functions as well as with key Clinical and Regulatory stakeholders.
• Responsible for the preparation and presentation of project team data to senior management and BOD to drive decision making and to support regulatory filings.
• Represent Stoke Therapeutics with key external stakeholders and partners as needed.

Required Skills & Experience:

• Advanced scientific degree (MD, or PhD, or PharmD). in a relevant discipline with at least ten years of post-graduate and drug development experience.
• Strong experience with drug development in the eye and/or CNS is required.
• 5+ years of experience leading cross-functional development teams, especially in late preclinical (pre-IND) through early clinical development
• Some experience with oligonucleotides or messenger RNA is preferred.
• Familiarity with GLP regulations and ICH/FDA guidelines is a plus.
• 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.

Travel:

This position will require approximately 20% travel to necessary meetings.

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.

Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events, and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.

Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.

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This is an opportunity for a clinician to join a fast-growing company focused on precision medicines for genetic diseases. Join Stoke’s experienced and dedicated team to lead the development of transformative therapies for life threatening diseases. We are seeking a talented, independent, and motivated clinician to help design, implement and communicate clinical trials for our Ocular Disease programs. This position reports to the Chief Medical Officer.

Key Responsibilities Include:

• Lead clinical development activities for Stoke’s Autosomal Dominant Optic Atrophy program under supervision of the Chief Medical Officer. Establish and implement the Clinical Development Plan for the program.
• Collaborate closely with the Clinical Development Operations team and be accountable for all deliverables of clinical trials under his/her direct responsibility.
• Contribute to the clinical content of all clinical and regulatory documents for the Autosomal Dominant Optic Atrophy program, including study design, writing protocols, INDs, CTAs, investigator brochures, CRF’s, CSRs, annual IND reports, and clinical expert reports.
• Represents the clinical function at health authority interactions
• Contributes to disease area strategy planning to influence the future portfolio
• Participate in analysis of clinical data, including safety monitoring in collaboration with Pharmacovigilance.
• Develop and maintain relationships with key global opinion leaders and Principal Investigators.
• Organize and present at relevant clinical advisory boards and SMCs.
• Author manuscripts, publications, or other documents intended for external audiences.
• Help ensure Clinical Study Team compliance with FDA, EMA, PMDA, ICH and GCP guidelines and internal SOPs.

Required Experience:

• M.D. or M.D./Ph.D.
• Board certified or eligible in a medical or pediatric subspecialty preferred.
• Expertise in Ophthalmology is required.
• Strong record of basic and/or translational research productivity.
• At least 2 years of experience in clinical research in an industry setting.
• Experience with orphan diseases or oligonucleotide therapeutics is an advantage.
• 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.
• 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.

Travel:

This position will require approximately 25% travel, both domestic and international.

Location(s):

This position will be primarily located in Cambridge, MA, and may also work occasionally from Bedford, MA.

Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.

Benefits & Compensation:

Stoke Therapeutics offers comprehensive and competitive employee benefits, including: medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.

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Stoke is seeking an enthusiastic, motivated Sr Manager, Clinical Operations. The candidate will lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical trial(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s), you will oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Stoke SOPs), within approved timelines and budgets. This position will report into the Senior VP, Development Operations.

Key Responsibilities:

• Leads all aspects of assigned clinical trial(s) (Natural History, Phase 1-3) and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and study team leadership capabilities.
• Actively participates in the development of department initiatives, including acting as lead on the development /definition of SOPs and processes.
• Utilizes project management skills to ensure consistency in processes and drive Clinical Operations performance.
• Responsible for the management and oversight of all study vendors (CRO) to ensure that Stoke’s clinical trials are getting the necessary resources and attention the vendor has committed to, ensures trial oversight plans are in place and updated as appropriate, ensures trial deliverables and performance goals are met and quality is maintained.
• Oversees the development of and adherence to clinical trial project timelines and ensures line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks.
• Provides input into clinical study protocols, informed consent forms (ICFs) and other clinical trial documents.
• Coordinates 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.
• Coordinates with CMC regarding drug forecasting and supply of drug products to sites.
• Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts.
• Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts.
• Participates in clinical trial scenario planning (estimates time and cost).

Required Skills & Experience:

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• Minimum of 6-8 years of progressive experience in clinical operations within biotech, pharmaceutical, CRO industry.
• Experience monitoring clinical studies and conducting and/or overseeing PSVs, SIVs, IMVs, and COVs are required.
• Rare Disease and Neurology trial experience are highly desirable.
• Proficiency in Microsoft Word, Excel, and Outlook, PowerPoint, and MS Project
• Strong written and verbal communication skills

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA.

Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.

Travel:

This position will require 10-15% travel.

Benefits & Compensation:

Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.

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Stoke is seeking a highly motivated, hands-on, and seasoned Business Systems Analyst to join a company pioneering treatments for genetic diseases. This role is a key member of the IT team and will be responsible for helping to create and deliver IT strategy in compliance with 21 CFR Part 11 for GxP systems that support Stoke’s business goals and objectives. This person will be primarily focused on the delivery and maintenance of integrated computer systems solutions to support Quality, Regulatory and Clinical Operations. This position will report to the Head of IT.

Key Responsibilities:

• Lead the design and delivery of IT solutions to support business requirements. This will involve direct stakeholder interface with regards to development, design, delivery, testing, validation, and training for systems that support Quality, Regulatory, and Clinical Operations.
• Deliver customer satisfaction through clear, timely communication and facilitation of expectations with stakeholders.
• Partner with stakeholders to deliver integrated solutions through formal Systems Development LifeCycle (SDLC) including project planning, analysis, and translation of business requirements into user, functional, and technical requirements, and application validation.
• Continuous partnership with business stakeholders to develop roadmap for implementation and refactoring of solutions to meet emerging business requirements and optimize existing systems and processes.
• Develop test cases and plans, conduct user testing, and monitor implementation for new systems, bug fixes and enhancements. Partner with the stakeholders to conduct user acceptance testing.
• Produce document manuals, SOPs and other relevant documents to describe application usage by the user community and operating procedures.
• Perform validation activities for new implementations and ongoing maintenance including drafting and updating documents for Computer Systems Validation (CSV).
• Propose solution recommendations and options to achieve business objectives, improve business processes/efficiency, and address process gaps.
• Bring assigned projects to successful conclusions (on time, on budget, and in scope).
• Stay abreast of emerging and evolving technology solutions.
• Additional projects as assigned.

Required Skills & Experience:

• Bachelor’s degree required. Advanced degree is a plus.
• Minimum of 7 to 10 years relevant experience as a business systems analyst in biotech or life sciences industry. The ideal candidate will have at least 5 years of experience working in a GxP environment.
• Experience in validating and implementing GxP systems for deployment into production through required testing as part of SDLC and computer validation practices.
• Familiarity or direct knowledge of electronic document management, regulatory submissions management, QMS, eTMFs, electronic signatures, and other computer systems that support Quality, Regulatory, and Clinical processes.
• The ideal candidate will also have experience with Veeva Vaults, especially QualityDocs, Submissions and eTMF.
• Familiarity with DIA reference model. V3 and later preferred.
• Experience in developing test cases and plans and executing UAT.
• Experience in Project Management required for the implementation of new and change management of existing computer systems.
• Knowledgeable in 21 CFR part 11, computer systems validation, Good Automated Manufacturing Practice (GAMP) standards.
• IT project management skills including budget and vendor management.
• Experience delivering systems training to end users.
• Strong analytical and problem-solving skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.
• Strong interpersonal and communication skills in addition to excellent documentation skills required. Ability to explain technical concepts to both technical and nontechnical audiences.
• Self-starter and ability to work independently.

Travel:

This position will require less than 5% travel.

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.

Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events, and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.

Benefits & Compensation:

Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.

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Stoke is seeking an enthusiastic, collaborative and experienced Scientist to join the Bioanalytical, DMPK and Biomarker Development group. This is a lab-based role, and the successful candidate will be responsible for:

• Antigen conjugation with carrier proteins, purification and characterization of conjugates.
• Manage outsourced generation of anti-drug antibodies for use in PK (pharmacokinetics), ADA (anti-drug antibody), and nAb (neutralizing antibody) assays as needed.
• Develop ADA methods and work with CROs to transfer, qualify/validate bioanalytical assays, and support assay implementation.
• Review study protocols, manage critical reagent lots, and monitor GLP sample testing.
• Develop high-quality assays to quantitate oligonucleotides in biological matrices to understand the PK, absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
• Partner with and support Toxicology.
• Present results at cross-functional team and lab meetings.
• Maintain accurate documentation of experiments in ELN.
• Prepare clear and accurate reports of internal and external projects as required.
• Help maintain the bioanalytical lab and keep the instruments running properly.

Essential Skills & Experience:

• Bachelor’s degree with 10+ years of experience, or Master’s degree with 8+ years of post-graduate experience, or Ph.D.
• Understanding of ADA and nAb assay, outlier identification, and cut point determination.
• Experience in the development of immunoassays (ELISA/MSD).
• Experience with transferring methods to CROs and managing activities for sample testing.
• Strong knowledge of ADME concepts and bioanalytical principles is desired.
• Good understanding of bioanalytical assay development, validation and implementation.
• Excellent problem-solving skills and ability to work as a team player in a dynamic environment.
• Excellent communication and presentation skills required.
• Proficient in standard Microsoft Office tools: Word, Excel, and PowerPoint.
• Strong attention to detail and organizations skills.
• Prior drug development experience in nucleic acids-based therapeutics is highly desirable.
• Basic understanding of FDA and ICH Guidance for bioanalysis and ADA evaluation.
• Experience in LC/MS based analysis, especially high-resolution LC/MS analysis, is a plus.

Benefits & Compensation:

Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.

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The Director of Regulatory Affairs reports to the SVP, Regulatory Affairs & Quality and will be responsible for developing and delivering global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio. This role will provide regulatory support for various departments, projects, and teams.

Key Responsibilities:

• Leads the development and implementation of regulatory strategy and activities.
• Represents RA in product development project teams advising on timelines, regulations, process, and requirements.
• Serves as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
• Provides regulatory guidance from early stage (pre-IND/CTA) through commercialization
• Identifies and evaluates regulatory risks and establish risk mitigation.
• Plans and executes successful regulatory agency meetings and interactions per regulatory strategy.
• Develops and implements global regulatory strategies and plans.
• Initiates and plans health authority meetings with global regulatory agencies.
• Prepares and delivers effective presentations for external and internal audiences.
• Contributes to the continuous improvement of existing processes and strategies, providing recommendations in their area of expertise.
• Identifies and monitors regulatory and policy issues.
• Develops risk assessment plans. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
• Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.

Required Skills & Experience:

• M.S. or Ph.D. in Life Sciences or related degree preferred.
• 7-8 years minimum of pharmaceutical/biotechnology industry experience in Regulatory Affairs lead role.
• Experience in rare disease drug development is highly desirable.
• Experience and comfort with a fast-paced biotech company environment
• International regulatory experience (US, EU and Japan) would be a plus.
• Knowledge and experience in interpretation of regulations, guidelines, and policy statements, etc.
• Experience in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs, including both clinical and pre-clinical aspects of the project; direct experience in interfacing with relevant regulatory authorities.
• Foster effective, positive interactions with regulatory agencies, and corporate partners.
• Demonstrate excellent leadership and communication skills
• Demonstrate strong organizational skills.
• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
• Well organized, self-motivated handworker, smart independent thinker, works well under pressure and deadlines, detail oriented, effective written and oral communication skills.

Location(s):

Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.

Since March 2020, Stoke’s office-based employees have been working from home and we have modified our business practices (including but not limited to curtailing or modifying employee travel, moving to partial remote work, and cancelling physical participation in meetings, events and conferences). We are continually assessing the impact of COVID-19 on our business and keeping in mind the best interests of our employees, patients, and business partners. For the foreseeable future, we anticipate the individual in this role will work from home and participate in meetings and company events virtually. At some point, we anticipate this role will return to working at one of our physical locations.

Benefits & Compensation:

Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.

Apply Here