Director, Clinical Systems & Data

Praxis is hiring a Director, Clinical Systems & Data. You would lead the strategy, roadmap, and delivery of the clinical systems and data capabilities that support Praxis’s clinical development and study operations. This includes translating clinical priorities and study milestones into clear technology priorities, making thoughtful investment and sequencing decisions, and driving delivery with urgency and accountability.

Within IT, you will own the clinical systems and data capability while partnering closely with Clinical Operations, Data & Analytics, Quality, Regulatory, and external technology providers. The role calls for creating clarity across functions, establishing decision rights, resolving competing priorities, and ensuring the systems and data supporting our clinical programs are reliable, scalable, secure, and fit for purpose.

You will provide leadership across clinical data engineering, data platform architecture, clinical systems delivery, and related validation activities. At the same time, you’ll stay close to the technology and the work—challenging designs, troubleshooting issues, escalating when needed, and applying sound judgment to keep delivery moving.

You will also help shape how Praxis uses clinical technology and data to work better. You’ll move the organization from fragmented or static workflows toward governed, reusable data products, analytics, and practical AI-enabled tools that help teams make better decisions and work more effectively. Success will include building an operating model that scales with the organization, strengthens inspection readiness and operational resilience, and reduces dependency on individual contributors.

Primary Responsibilities

• Own the clinical systems and data strategy and roadmap; translate clinical development priorities and study milestones into sequenced investments, clear priorities, and measurable outcomes.
• Lead and develop the clinical data engineering and data platform capability, including architecture, data flows, integrations, access controls, data quality, cloud platforms, and reusable data products across clinical systems.
• Create clarity across IT and functional teams by establishing decision rights, aligning stakeholders on requirements and acceptance decisions, resolving competing demands, and driving timely decisions.
• Partner with Clinical Operations and other functional teams to improve the reliability, usability, and scalability of clinical systems and technology-enabled study workflows.
• Lead the evolution from fragmented or static workflows toward governed, reusable analytics and practical AI-enabled tools that create meaningful value for clinical teams.
• Lead system implementations, integrations, enhancements, upgrades, issue resolution, and transition to ongoing support; coordinate internal teams, vendors, and implementation partners across dependencies, risks, and milestones.
• Own the IT relationship with clinical technology vendors and service providers; establish service expectations, evaluate platform choices, manage performance, and inform investment and renewal decisions.
• Partner with Quality and functional owners on risk-based computerized systems assurance and validation, including requirements, test strategy, traceability, validation evidence, vendor deliverables, remediation, and inspection readiness.
• Establish and maintain strong standards for system lifecycle management, change control, access governance, security, data stewardship, incident management, business continuity, and operational resilience.
• Provide hands-on technical leadership when needed, including architecture reviews, troubleshooting, vendor escalation, and evaluation of new technologies; build a durable operating model that enables the clinical organization to scale.

Qualifications and Key Success Factors

• 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, with the ability to challenge designs, identify dependencies, and guide delivery.
• 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. Creates clarity, builds trust, and holds teams accountable for outcomes.
• A strong ownership mindset, with the ability to step into ambiguity, surface risks early, make decisions with appropriate urgency, and stay engaged through resolution. Comfort balancing speed with rigor, particularly in regulated environments, and knowing when to move quickly, when additional diligence is needed, and how to build controls that enable both.
• Clear, direct communication and the ability to adapt to different audiences while remaining technically engaged and contributing hands-on when needed.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.