Our commitment to people with muscle diseases
is our greatest strength

Head of IT

Department: 205 IT

Location: Waltham, MA

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne Therapeutics is looking for a strategic leader to define the IT architecture and systems as the organization moves into a rapid growth phase. The opportunity for the ideal candidate will be to shape the future of technology at Dyne while ensuring the organization is built for security and scale.

Dyne Therapeutics is seeking a Head of IT to support our business as it grows into a clinical stage biotech company and prepares for a transition to a commercialized business. The ideal candidate will have 10+ years of experience with a solid understanding of Information Technology and cGXP best practices with 5+ years of computer system validation (CSV) experience in an FDA regulated industry. Areas of focus will be implementation of validated computer systems, system design, IT Architecture, workflow development, project management and desktop support. This position will be responsible for implementing and maintaining ITGC and IT SOX controls and responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation and validated computer systems. Candidates should demonstrate initiative and ability to navigate ambiguity and a willingness to grow as the company scales in size.

This is a full-time position based in Waltham, MA and reports directly to the VP, Finance or his/her designee.

Primary Responsibilities Include:

IT Architecture

  • Refine the current IT design and improve for scale
  • Lead the design and implementation of IT infrastructure at Dyne’s new offices
  • Create a scalable architecture including cloud and on-premise solutions

IT Business Management

  • Implement and manage security and compliance controls including strong vendor management
  • Build and implement a multi-year scalable IT strategy and vision for the company across functions
  • Provide thought leadership in architecting business applications and define an enterprise-wide integration vision and strategy for all business applications
  • Partner with the Finance organization to facilitate the department’s forecasting process and ensure conformance to IT operating expense budget
  • Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines
  • Educate, coach, mentor and train the IT stakeholders and cost center owners on best practices and methodologies
  • Be autonomous in decision making, but collaborate when needing to escalate to senior leadership team
  • Serve as the single point of contact for all implemented software across the company

IT Vendor Management

  • Responsible for managing relationships with specific vendors and serving as the IT organization's point of contact
  • Review vendor contracts and analyze proposals and quotes; review and process vendor Statements of Work and assist with creation of capital asset requests
  • Support the facilitation of strategic vendor business reviews; research, interview and negotiate with vendors to obtain prices and specifications
  • Conduct periodic review of software/hardware maintenance contract renewals and proactively contact vendors for quotes and submit purchase requisitions
  • Proactively identify process improvements and help find efficient solutions

User Support

  • Provide on-site expertise and technical knowledge of laptops, printers, and mobile computing devices
  • Arrange end user on-boarding, off-boarding, provisioning, and de-provisioning
  • Provide support for conference rooms

Knowledge & Skills

  • Knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization
  • Experience supporting all levels including C-suite executives, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals, as well as global regulatory filings
  • Solid knowledge of vendor management and technology business management processes and methodologies
  • Experience with software development life cycle in regulated environment
  • Strong facilitation skills and ability to influence and negotiate positive outcomes
  • Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams in person, over the phone and via email
  • Able to work both independently and in a team-oriented, collaborative environment
  • Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
  • Effective influencing and negotiating skills in an environment with cross functional teams, contractors, resources, and third-party vendors
  • Understanding of Identity based security solutions
  • Cybersecurity certification preferred
  • Experience with cloud technologies such as AWS, Azure
  • Experience with Microsoft 365, cloud support, and experience in transitioning and implementing MS SharePoint

Education & Experience:

  • Bachelor's degree or equivalent experience in technology or related field
  • Ten plus (10+) years related experience
  • Experience in biotech highly desirable
  • Three (3) years of Budget and Vendor management domain experience preferred
  • Expertise in both PC and MAC environments
  • Working knowledge of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance
  • Experience working in a SOX environment and working with external auditors

 

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.


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