Director, Clinical Systems – Data Management

Posted 1hrs ago

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Job Description

Director leading clinical systems and data strategy for Praxis, a CNS biopharmaceutical company. Driving regulated clinical technology, data platforms, analytics, and scalable study operations.

Responsibilities:

  • Lead the strategy, roadmap, and delivery of clinical systems and data capabilities supporting clinical development and study operations
  • Translate clinical priorities and study milestones into technology priorities, investment decisions, and sequenced delivery
  • Own the clinical systems and data capability within IT
  • Partner with Clinical Operations, Data & Analytics, Quality, Regulatory, and external technology providers
  • Lead clinical data engineering, data platform architecture, clinical systems delivery, and validation activities
  • Establish decision rights, align stakeholders, resolve competing priorities, and drive timely decisions
  • Improve the reliability, usability, and scalability of clinical systems and technology-enabled study workflows
  • Evolve fragmented workflows toward governed, reusable analytics and practical AI-enabled tools
  • Lead implementations, integrations, enhancements, upgrades, issue resolution, and transition to ongoing support
  • Coordinate internal teams, vendors, and implementation partners across dependencies, risks, and milestones
  • Own IT relationships with clinical technology vendors and service providers
  • Partner on computerized systems assurance and validation, inspection readiness, remediation, and vendor deliverables
  • Establish standards for lifecycle management, change control, access governance, security, data stewardship, incident management, business continuity, and operational resilience
  • Provide hands-on technical leadership through architecture reviews, troubleshooting, vendor escalation, and technology evaluation
  • Build a durable operating model enabling the clinical organization to scale

Requirements:

  • 10+ years of relevant experience across clinical systems, clinical data platforms, data engineering, technology delivery, or related disciplines, including leadership of complex cross-functional initiatives
  • Experience supporting pharmaceutical or biotechnology clinical development and delivering technology or data capabilities in a regulated environment
  • Strong understanding of the clinical technology ecosystem, including data integrations, cloud platforms, data architecture, analytics, and the operational needs of clinical teams
  • Experience with computerized systems validation, computer software assurance, GxP expectations, change control, data integrity, and inspection readiness
  • Ability to translate clinical and business priorities into practical roadmaps, investment decisions, delivery plans, and measurable outcomes, while effectively managing technology vendors and budgets
  • Technical fluency across data flows, APIs, integration patterns, cloud data platforms, and analytics tools
  • Experience leading requirements definition, testing, user acceptance, change management, training, and transition to ongoing support
  • Demonstrated ability to lead technical teams and influence cross-functional stakeholders without relying solely on formal authority
  • Strong ownership mindset; ability to step into ambiguity, surface risks early, make decisions with appropriate urgency, and stay engaged through resolution
  • Comfort balancing speed with rigor in regulated environments
  • Clear, direct communication and ability to adapt to different audiences while remaining technically engaged and contributing hands-on when needed
  • Alignment with Praxis values of Trust, Ownership, Curiosity, and Results
  • Comfort with regular computer and office-equipment use, clear communication, occasional movement, screen work, basic hand coordination, and focus

Benefits:

  • 99% of the premium paid for medical, dental and vision plans
  • Company-paid life insurance
  • Company-paid AD&D
  • Disability benefits
  • Voluntary plans to personalize coverage
  • Dollar-for-dollar 401(k) match up to 6% on eligible contributions
  • Long-term stock incentives
  • ESPP
  • Discretionary quarterly bonus
  • Extremely flexible wellness benefit
  • Generous PTO
  • Paid holidays
  • Company-wide shutdowns