- Collaborate closely with cross-functional leaders to develop comprehensive strategies that drive business success and operational excellence, optimizing product development, and establishing commercialization processes
- Align technology initiatives with the overarching business objectives, guaranteeing that Dyne's corporate technology supports its operations and objectives including digital transformation, cybersecurity, and commercial readiness
- Provide the strategies and technology solutions to enable the launch of products globally
- Implement commercial, manufacturing and supply chain, and ERP business processes and systems
- Lead and grow a strong global IT team, fostering a culture of innovation, collaboration, and continuous improvement, providing mentorship and professional development opportunities to team members to enable efficient and scalable operations, with particular focus to building of commercial capabilities
- Define the operating model to enhance IT's capabilities
- Continue to scale robust governance protocols to ensure product/platform compliance, policy development, and management of risks
- Continue to scale a robust IT Security organization to protect Dyne's assets and ensure global regulatory and privacy compliance
- Evolve the cross-functional technology governance body to ensure alignment of technology and business goals
- Develop an enterprise AI Strategy and prioritization framework and an enterprise data management strategy including retention and governance standards
- Evolve and right size the ITGC, IT SOX, and SEC Cybersecurity controls
- Responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation of validated computer systems.
- Partner with Finance to develop and lead the IT portfolio budget, ensuring sufficient resources are allocated for technology investments, returns are realized, and future investments are balanced across business needs, while providing a stable and efficient support operating model
- Direct the development of the IT sourcing strategy and provide executive oversight for strategic vendor and partner relationship management
- Provide strategic direction for cybersecurity program using a risk-based approach, direct internal and external services to execute on a proactive strategy, and ensure program agility to adapt to and evolving threat landscape
- Drive commercial readiness in IT processes and related business processes to ensure business achieves timely benefits from investments
- Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are optimized for business needs, operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines
- Foster strong relationship[s, including proactive planning and cultivation of external partnerships
- Bachelor's degree or equivalent experience in technology or related field
- Twenty plus (20+) years related experience, including 5+ years as a strategic IT executive within a biotech
- Commercial biotech build experience across commercial, manufacturing and supply chain, and ERP business systems in a strategic, head of IT or CIO role
- Demonstrated initiative and ability to navigate ambiguity, and the ability to grow as the company scales in size
- Experience building a commercial ready IT infrastructure, processes, and controls
- Working expertise of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance
- Expert knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization
- Ability to translate business needs into a strategic IT roadmap, communicate that roadmap at all levels of the organization, and effectively implement that roadmap into operational success for the organization
- Experience supporting all levels, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals
- Expert knowledge of vendor management and technology business management processes and methodologies
- Extensive experience with software development life cycle in regulated environment
- Excellent communication skills (verbal, written, presentation) and ability to communicate well with stakeholders at all levels
- Ability to lead 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
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Chief Information Officer - Waltham, United States - Dyne Therapeutics Inc
Description
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit , and follow us on X , LinkedIn and Facebook .
Role Summary:
The Chief Information Officer (CIO) is a key role responsible for defining and evolving Dyne's technology and digital strategy, vision, and roadmap in line with the business strategy, to drive innovation, efficiency, and competitive advantage to enable organizational success, growth, and commercial readiness. This role requires an understanding of and deep experience with the full drug development lifecycle from research and development through commercialization. This role requires a strategic leader experienced with preparing an organization's integrated technology infrastructure for commercialization and taking products to market. This leader is responsible for developing an IT roadmap, identifying, and executing on initiatives that drive tangible business outcomes that accelerate drug development timelines, ensure data integrity, compliance, and operational effectiveness.
This is a full-time position based in Waltham, MA without the possibility of being remote.
Primary Responsibilities Include:
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.
