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.
Senior Data Manager, Clinical Operations
Stoke is seeking an enthusiastic, motivated Sr Clinical Data Manager. The candidate will oversee execution of data management activities for assigned clinical trial(s) and contribute to overall clinical study data strategy and planning. In close collaboration with Clinical Operations Trial Lead(s), will ensure compliance with quality standards (including ICH GCP, local and federal regulations and Stoke SOPs), within approved timelines and budgets. This position will report into the Director, Head of Clinical Data Management.
Key Responsibilities:
- Responsible for oversight of data management activities performed by CRO’s and third-party vendors to ensure timely execution of studies in assigned clinical program(s) in addition to compliance with quality standards (including ICH GCP, 21CFR Part 11, local regulations and Stoke SOPs).
- Responsible for leading all data management related activities from protocol synopsis through database lock and submission.
- Provide input into clinical study protocols, informed consent forms (ICFs) and other clinical trial documents as required
- Responsible for review and approval of all Data Management related documentation (DMP, Data validation and transfer specs etc).
- Support timely and efficient database lock by participating in data review / reconciliation efforts.
- Manage and assist in analysis and review of clinical data deliverables for publications, meetings, regulatory submissions, interim analysis and quarterly data review meetings.
- Provide EDC super user expertise, management of study URL’s and provide ongoing database training for new staff.
Represents data management function at the Clinical Study Team (CST) level and participate in vendor project team meetings as SME to ensure expectations are aligned between the CRO and Stoke for all data related data deliverables and associated timelines.
- Write and review work instructions and SOPs for data management activities Provide and enable solutions for complex problem solving that align with the Stoke values.
- Lead cross-functional Data Communication Planning meetings
- Lead and manage internal Data Review meetings
- Collaborate with project managers and team members to help determine data strategy for clinical trials to ensure high quality data
Required Skills & Experience:
- BS degree in Life Science, math, computer science or another related field required.
- 8-10 years of progressive clinical data management experience within biotech, pharmaceutical, CRO industry.
- Proven track record of strong project management skills and experience managing data management activities for small – large drug development programs
- Ability to handle multiple development programs simultaneously.
- Good understanding of CDISC standards, and experience implementing standards
- Strong knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
- Thorough command of FDA and ICH GCP regulations and industry standards applicable to clinical data management systems and 21 CFR Part 11 requirements
- Vendor management and oversight experience
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Rare Disease and Neurology trial experience are highly desirable.
- Proficiency in Microsoft Word, MS Project, Excel, and Outlook, PowerPoint, and MS Project
- Strong written and verbal communication skills
- SAS or alternative programming experience desirable
- Proficiency with data visualization tools desirable
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs ·
- Experience with all phases of development
- Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. ·
- Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
Location(s):
This position is based in Cambridge, MA.
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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Director/Senior Director, Pharmacovigilance
The Director/Sr. Director, Pharmacovigilance (PV) Operations will design, implement and manage the company’s PV system and insure adherence to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to the overall global PV operations strategy across Stoke’s portfolio including case management, database strategy, vendor oversight, compliance, inspection readiness, budget, contract management, and trainings. The Sr. Director of PV Operations reports to the Chief Medical Officer.
This PV role is all about ensuring patient safety and working collaboratively together and cross-functionally to bring safe and effective medicines to our patients. This opportunity will allow you to drive the PV function at Stoke. It is an exciting time to work at Stoke as we expand our pipeline of RNA medicines and grow the company into a global organization.
Key Responsibilities:
- Provides strategic planning, oversight, and management of Stoke PV Operations activities.
- Provides vendor oversight and management for all outsourced PV activities, including establishing and monitoring key quality and compliance metrics.
- Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and safety requirements, per ICH; US and international regulations and guidelines; and EU Good Pharmacovigilance Practice (GVP).
- Designs and builds a PV system and internal safety database to support the department needs, including specific workflows and reporting/querying functionalities and is fully compliant with the applicable worldwide Health Authority PV regulations.
- Provides oversight of systems and MedDRA updates in collaboration with the relevant vendor(s).
- Develops and implements an inspection readiness program with the contribution of non-PV stakeholders.
- Responsible for compliant and quality execution of all operational activities related to case management and related activities.
- Oversees timely submissions of expedited reports to the FDA & other health authorities.
- Identifies deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
- Establishes a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the Quality Assurance department.
- Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate trials and products.
- Contributes to and implements department SOPs and work instructions related to the PV activities.
- Effectively collaborates with key stakeholders at all levels in the organization.
- Leads Internal Safety Review Committee meetings
- Participates in departmental and cross functional risk assessment, technology development, and process improvement initiatives.
- Represents PV as a leader on project teams, other departments, and committees.
- Hires additional PV team members to build a top-notch PV organization for Stoke.
- Other duties as assigned by the manager.
Required Skills & Experience:
- Life Science Degree or Healthcare Professional (PharmD, PhD, MS, BS, RN, or RPh).
- A minimum of 10 years of experience in PV Operations in the biopharmaceutical industry, with at least 5 years of leadership and managerial experience in overseeing global/regional PV operations.
- Experience in rare diseases is preferred. Neurology trial experience is desirable.
- Prior experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance (including major PV inspections).
- Expert knowledge of global PV regulatory guidelines and legislation requirements, e.g., US Code of Federal (CFR) regulations, European Union (EU), Guideline on GVP and ICH Guidelines.
- Experience and extensive working knowledge of MedDRA and proprietary safety databases.
- Significant experience working with CROs, vendors, and relationship management.
- Strong managerial skills across countries and ability to partner closely and effectively cross-functionally.
- Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
- Ability to combine PV expertise with exceptional leadership (strategic thinking, people, and resource management).
Location(s):
This position is based in Cambridge, MA.
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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Paralegal
The Paralegal will to support Stoke’s legal department in a wide variety of corporate, contract, intellectual property, compliance, and legal operations matters. This position reports to the Deputy General Counsel and will work closely with all members of the legal department.
Key Responsibilities:
- Assist with corporate governance matters including preparation and maintenance of board and committee minutes, resolutions, consents and record books.
- Organize and maintain Intellectual Property (IP), compliance and other legal operations records and filings.
- Negotiate a variety of template-based contracts, including non-disclosure agreements, consulting agreements, material transfer agreements, data privacy addendums and other related agreements with Counsel support.
- Provide administrative support as necessary to the legal department, including setting up new law firms and vendors in new vendor and e-billing systems and managing billing and account inquiries for legal department vendors.
- Support ongoing company-wide initiatives, including policy development, template standardization and adoption of contract-related technologies.
Required Skills & Experience:
- Bachelor’s degree, Associate’s degree or paralegal certification is required.
- A minimum of 5 years of paralegal experience inhouse at biotech/biopharma company (can be combined with relevant experience at a law firm).
- Familiarity with IP docketing and management systems (such as CPI) and experience with PCT and foreign patent procedures is highly preferred.
- Outstanding attention to detail, organizational and strong record keeping skills are required for this role.
- A positive attitude and excellent interpersonal, oral and written communication skills are important.
- Ability to work independently and collaboratively and with a high level of confidentiality and discretion in handling of legal matters is critical for this role.
- Ability to multi-task and handle multiple assignments simultaneously in a fast-paced, deadline-driven environment.
- Proven ability to interface with outside counsel, vendors, collaborators, and internal functions at all levels is required.
- Willingness to grow and learn new responsibilities.
- Notary license in Massachusetts or willingness to get one.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA, and this position can be located at either.
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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Senior Research Associate, Discovery Biology
Stoke is seeking to hire a Senior Research Associate with a strong background in cell and molecular biology research. The candidate will report to an Associate Principal Scientist in the Discovery Biology Group and support ongoing research efforts in developing oligonucleotide-based therapies. The candidate is expected to perform the following activities:
Key Responsibilities:
- Work in aseptic conditions and maintain cultures of various cell types.
- Screen and evaluate oligonucleotide-based drug candidates and plasmids in cell-based assays by nucleofection, transfection.
- Perform cell and molecular biology techniques such as RNA and protein isolation, RT-PCR, RT-qPCR, in 96 and 384 well formats.
- Perform protein assays- western blot, ELISA and MSD assays.
- Troubleshoot experiments, analyze and interpret data, participate in development of new assays.
- Maintain accurate documentation of experiments in electronic lab notebook (ELN).
- Write technical reports and protocols, with guidance from supervisor.
- Present research findings at group meetings and occasional company-wide and external meetings, as necessary.
- Work independently as well as collaborate with peers in a result-oriented research environment.
Required Skills & Experience:
- Senior Research Associate: B.S. with a minimum of 5+years post-graduate experience in molecular and cell biology research, or M.S. with a minimum of 2 years post-graduate experience in molecular and cell biology research
- Strong hands-on experience in RNA isolation techniques RT-qPCR and protein assays.
- Mammalian cell culture and cell-based assays is a must.
- Experience with viral vectors is a plus but not required.
- Strong organizational and recordkeeping skills.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.
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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Clinical DMPK Study Manager
Stoke is seeking an enthusiastic, motivated Scientist to join Drug Metabolism and Pharmacokinetics (DMPK) team. Drug Metabolism and Pharmacokinetics (DMPK) is a scientific discipline that assists discovery teams in selecting optimal drug candidates to enter clinical trials. In addition, this team helps in evaluation of safety and adequate potency of the drug during discovery and development. The candidate will be a liaison between DMPK and clinical operations team. This position will report into the VP, DMPK.
Key Responsibilities:
- Collaborate with DMPK scientists and clinical operations team to lead DMPK operations aspects of assigned clinical trial(s) (Phase 1-3).
- Participate in clinical study team meetings and provide updates on vendor and study operations.
- Coordinate the relevant and timely exchange of DMPK related information with clinical team to support clinical trials.
- Coordinate all set-up, planning and maintenance of project with CRO Project manager to operationalize supplies to the sites and troubleshooting with study sites.
- Responsible for preparing documents for sample collection and sample processing for bioanalytical and biomarker testing.
- Responsible for tracking the samples e.g. shipment delays, temperature excursions and deviations.
- Establish relationship with central lab and manage the timelines and budgets for central labs and bioanalytical lab vendors.
- Participate in vendor calls and communicate with study vendors (CRO) to ensure that Stoke’s clinical trials are getting the necessary resources and attention the vendor has committed to.
- Contributes to trial oversight plans.
- Oversee the development of lab manuals, adherence to clinical trial project timelines and ensures line function heads are kept informed.
- Provide input into clinical study protocols, informed consent forms (ICFs) and other clinical trial documents.
- Participating in data review / reconciliation efforts.
Required Skills & Experience:
- BSc., MSc. Or PhD. in a scientific or healthcare discipline.
- Minimum of 2+ years of progressive experience working within drug development and/or clinical trial operational teams.
- Technical experience, attention to detail and good organizational skills to support bioanalytical sections of clinical studies.
- Experience working with contract research organizations and central laboratories.
- Experience with project management and timeline management.
- Knowledge of GLP/GCP Bioanalysis is desired.
- Rare Disease and Neurology trial experience is 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. This position is based in Bedford, MA.
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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Associate Scientist – Medicinal Chemistry
Stoke is seeking a highly motivated Associated Scientist to join a company pioneering genetic disease treatments. The candidate will be expected to perform the following activities:
Key Responsibilities:
- Working with a small team in coordination with a Ph.D. scientist, the scientist in this role will design, execute, and troubleshoot research efforts independently.
- Synthesis and purification of oligonucleotides from milligram to multigram scale using automated synthesis system such as Mermade and Äkta.
- 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.
- Purification of oligonucleotides: De-salting, HPCL, or other techniques.
- Formulation of oligonucleotides into solutions of measured concentration.
Required Skills & Experience:
- Bachelor’s degree in Chemistry with 7+ years of related experience, or Master’s degree in Chemistry with 5+ years of related post-graduate experience.
- Experience in nucleic acid chemistry and/or oligonucleotide synthesis is a plus
- Good team-working and communication skills are essential.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.
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; a Tuition Assistance Program, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.
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Senior Infrastructure and Security Engineer
Stoke is seeking a highly motivated, hands-on Senior Infrastructure and Security Engineer 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 implement and support IT infrastructure and ensuring alignment with industry standards and best practices around compliance and security. This position will report to the Head of IT.
Key Responsibilities Include:
- Lead the implementation and enforcement of corporate, regulatory and risk management policy configurations across IT systems. Partner with system owners to address the same across business applications.
- Assist in developing, implementing, and maintaining standards, technologies, processes, and procedures related to both information security and IT operations.
- Ensure availability and capacity of networks and systems.
- Develop, implement, and maintain tools and reports around network and systems availability, capacity, performance, and security.
- Coordinates, administers, monitors, and maintains network, server, and security infrastructure.
- Lead security initiatives: vulnerability and risk management of systems, incident handling, Conditional Access and MFA, DLP, pen testing.
- Participate in helpdesk support as required.
- Additional projects as assigned.
Required Experience:
- Bachelor’s degree required.
- Minimum of 3 to 5 years relevant experience. Experience in biotech or life sciences industry a plus.
- Working experience with Active Directory, Azure and Office 365 configuration and security capabilities such as Conditional Access, MFA, and SAML SSO.
- Experience with VMware vSphere
- Experience with endpoint and server security tools such as anti-virus/malware, EDR, encryption.
- Working network experience including strong understanding network fundamentals, routers, switches, WAN, LAN, VPN, firewalls, and other internetworking technologies
- Working experience with network services like CA and certificates, DHCP, DNS, IDS, etc.
- Strong fluency with Windows desktop and server, Mac OS, and Linux with special emphasis on configuring and hardening endpoints and servers.
- Experience with monitoring and log management tools required.
- Knowledge of at least 1 scripting language such as Bash, PowerShell, Python.
- Familiarity with Infrastructure as Code concepts and strong desire to automate as much as possible.
- Experience in Project Management required for the implementation of new and change management of existing network and systems including vendor management.
- Knowledgeable of compliance and security standards such as CIS/ISO/NIST, GDPR/CCPA, SOX, and 21 CFR part 11 and computer systems validation.
- Strong analytical and problem-solving skills required, including a thorough understanding of how to interpret 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):
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.
Apply Here
Senior Medical Director/Medical Director, Ophthalmology
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.