Director, Clinical & Regulatory Information Systems

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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