Job Description

NJ based Clinical Research Org. seeks a strategic, operationally minded, and hands-on Director of IT 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.

This is not a "heads-down" role—it's a leadership position that seeks strategic vision, team oversight, and active engagement in execution.  The IT department is undergoing transformation. This is a unique opportunity where you’ll be  responsible for restructuring, mentoring, and rebuilding a high-performing IT organization that can support our mission-critical clinical systems and digital reshaping initiatives  

Key Responsibilities

• Lead a diverse internal IT team across five core functions, maintaining visibility into each at a strategic (2,000-ft) level
  
• Evaluate and restructure the current IT org chart — identify gaps, reassign roles, and optimize FTEs vs. contractors
  
• Build strong partnerships with clinical and operational teams to ensure IT supports user needs
  
• Guide the migration of systems and databases (Oracle, .NET, Git, etc.) to the cloud and recommend optimal platforms (e.g., evaluating Aurora vs. Oracle)
  
• Oversee the development and validation of programs using technologies such as  C# ,  .NET ,  Oracle ,  Medidata Rave , and  SQL for data extraction, transformation, and loading (ETL).
  
• Direct the creation of high-quality graphical reports and dashboards using  Business Intelligence tools , providing actionable insights for clinical trial progress and outcomes.
  
• Direct application development for both internal and external stakeholders, including Clinical Trial Management Systems (CTMS), IWRS/IVRS platforms, and reporting systems ( Power BI, RAVE )
  
• Support  CFR Part 11/GxP -compliant systems, focusing on documentation, validation, and specifications
  
• Collaborate on digital transformation and modernization of legacy systems — including redeployment of government-developed tools into commercial use
  
• Ensure proper IT participation in every new client setup, including Medidata and internal systems integration
  
• Quantify, document, and communicate IT’s alignment with business goals
  
• Participate in strategic planning, budgeting, and vendor oversight to ensure ROI and performance from external providers
  

Qualifications

• BS degree
  
• 10+ years of progressive IT experience, with at l east 3 years in a Director or equivalent leadership role
  
• Proven success  managing cross-functional IT teams (development, infrastructure, validation, etc.)
  
• Experience in  biotech, life sciences, clinical research, healthcare ,  or regulated environments
  
• In-depth understanding of clinical trial phases, data flow, and regulatory requirements (e.g.,  CDISC standards, 21 CFR Part 11).
  
• Strategic thinker with operational execution skills — able to go from 50,000 feet to ground level as needed
  
• Track record of  change management, team restructuring, and mentoring talent
  
• Strong communication and collaboration skills with technical and non-technical stakeholders
  
• Background in  hybrid IT environments , ideally across government and commercial projects
  

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