Director, Clinical Systems – Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the strategy, roadmap, and implementation of clinical systems and data capabilities that support clinical development and study operations.

• Convert clinical priorities and study milestones into technology priorities, financial investments, and scheduled delivery plans.

• Take ownership of clinical systems and data capabilities within the IT department.

• Collaborate with Clinical Operations, Data & Analytics, Quality, Regulatory, and external technology partners.

• Oversee clinical data engineering, data platform architecture, clinical systems implementation, and validation processes.

• Define decision rights, align stakeholders, resolve conflicting priorities, and facilitate timely decision-making.

• Enhance the reliability, usability, and scalability of clinical systems and technology-driven study workflows.

• Transition disjointed workflows towards governed, reusable analytics and practical AI-driven tools.

• Manage implementations, integrations, enhancements, upgrades, issue resolutions, and the transition to ongoing support.

• Coordinate internal teams, vendors, and implementation partners across dependencies, risks, and milestones.

• Maintain IT relationships with clinical technology vendors and service providers.

• Collaborate on computerized systems assurance and validation, inspection readiness, remediation, and vendor deliverables.

• Set 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 assessment.

• Develop a sustainable operating model that enables the clinical organization to scale effectively.

⛳️ Requirements

• Over 10 years of relevant experience in clinical systems, clinical data platforms, data engineering, technology delivery, or related areas, with leadership of complex cross-functional initiatives.

• Experience in supporting pharmaceutical or biotechnology clinical development and delivering technology or data capabilities in a regulated environment.

• Strong comprehension of the clinical technology ecosystem, encompassing data integrations, cloud platforms, data architecture, analytics, and the operational requirements of clinical teams.

• Proficiency in computerized systems validation, computer software assurance, GxP standards, change control, data integrity, and inspection readiness.

• Ability to convert clinical and business priorities into actionable roadmaps, financial decisions, delivery strategies, and measurable results, while effectively managing technology vendors and budgets.

• Technical proficiency across data flows, APIs, integration patterns, cloud data platforms, and analytics tools.

• Experience in leading requirements definition, testing, user acceptance, change management, training, and the transition to ongoing support.

• Proven capability to lead technical teams and influence cross-functional stakeholders without relying solely on formal authority.

• Strong ownership mentality; adept at navigating ambiguity, identifying risks early, making timely decisions, and remaining engaged until resolution.

• Ability to balance speed with thoroughness in regulated environments.

• Clear and direct communication skills, with the ability to adapt to various audiences while remaining technically engaged and contributing hands-on when necessary.

• Alignment with Praxis values of Trust, Ownership, Curiosity, and Results.

• Comfortable with regular use of computers and office equipment, clear communication, occasional physical movement, screen work, basic hand coordination, and sustained focus.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-paid life insurance.

• Company-paid accidental death and dismemberment (AD&D) insurance.

• Disability benefits.

• Voluntary plans to customize coverage.

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonus.

• Highly flexible wellness benefit.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.