Director, IT
Location: Princeton, NJ (Mostly remote with some onsite collaboration required - only EST candidates in consideration at this time)
Employment Type: Full-time, Direct Hire (Salaried) About the Role
We are seeking a strategic, operationally minded, and hands-on IT Leader to lead and evolve our internal technology function across both government and commercial programs. The ideal candidate will be an experienced IT leader who can synthesize technical complexity into clear, actionable plans that align with clinical and business goals. You’ll step into a team in transition, with responsibility for restructuring, mentoring, and developing a high-performing IT organization to support clinical systems and digital transformation initiatives. The ideal candidate brings deep experience in regulated clinical environments and is ready to take ownership of an evolving IT function— with strong visibility and cross-functional influence . This is not a "heads-down" role — it's a leadership position that demands strategic vision, team oversight, and active engagement in execution. You’ll inherit a department in flux and be responsible for restructuring, mentoring, and rebuilding a high-performing IT organization that can support our mission-critical clinical systems and digital transformation initiatives. This role is ideal for someone who can “ land the plane ” by synthesizing complex technical topics into actionable, business-aligned strategy. You’ll be responsible for stabilizing and reshaping the IT function while ensuring it directly supports the clinical and operational mission of the company. Key Responsibilities
- Lead and manage a diverse IT team across five core functions, maintaining high-level (2,000-ft) visibility into each.
- Evaluate and restructure the current IT organization — reassign roles, identify skill gaps, and optimize the FTE vs. contractor mix.
- Partner cross-functionally with clinical, operational, and executive teams to deliver user-centric IT solutions.
- Oversee cloud migration of internal systems and databases (Oracle, .NET, Git, etc.); evaluate and implement platforms such as AWS Aurora.
- Direct application development for internal and client-facing systems (e.g., CTMS, IWRS/IVRS, Power BI, RAVE).
- Lead data reporting and BI efforts, including graphical dashboards to support clinical trial progress and operational KPIs
- Ensure compliance with CFR Part 11/GxP regulations including documentation, validation, and audit readiness.
- Modernize legacy systems and support digital transformation across both commercial and government-funded projects.
- Participate in all new client onboarding , ensuring seamless IT integration with platforms like Medidata RAVE.
- Quantify and communicate IT’s business value through clear metrics, strategic planning, and budgeting input.
- Oversee vendors and contractors , ensuring ROI, performance, and alignment with internal goals.
- Bachelor’s degree in a related field.
- 10+ years of progressive IT experience, including at least 3 years in a leadership role
- Proven success managing cross-functional IT teams : development, infrastructure, validation, etc.
- Experience in regulated environments such as biotech, life sciences, clinical research, or healthcare.
- Comfortable toggling between strategic oversight and operational execution
- Adept at engaging both highly technical staff and non-technical business stakeholders
- Familiar with clinical systems and trial platforms such as CTMS, Medidata RAVE, EDC, and related tools
- Strong understanding of CDISC standards , 21 CFR Part 11 , GCP, and system validation.
- Demonstrated ability in change management , org restructuring, and talent development.
- Experience in hybrid IT environments , ideally supporting both government and commercial projects.
- Excellent communication skills with both technical teams and non-technical stakeholders.
- Programming/Platform: .NET, C#, SQL, Oracle, Git
- Cloud: AWS (Aurora or equivalent) cloud migration and architecture
- Reporting/BI: Power BI, Business Intelligence tools
- Clinical Systems: CTMS, Medidata RAVE, IWRS/IVRS
- Compliance: CFR Part 11 , GxP, validation/documentation systems
- Strategic and grounded — able to zoom out for vision and dive in for execution.
- Transparent communicator — builds trust across departments.
- Collaborative and accountable — earns buy-in from clinical and business teams.
- Curious, analytical, and decisive — challenges the status quo and makes data-backed decisions.
- Hands-on leader — not afraid to do the work, mentor others, or make hard calls.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M2
#LI-CB5 Ref: #558-Scientific
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