Director, Enterprise Applications

Role Summary

Director of Enterprise Applications will own the business systems supporting Nurix's path from clinical trials through commercialization. They will serve as the primary IT partner to Clinical Operations, Regulatory, Quality, and Commercial leadership, ensuring the technology they rely on works and evolves with the business. The scope includes clinical systems (EDC, eTMF, pharmacovigilance, regulatory submissions), quality/training platforms, and emerging commercial systems. This is a strategic, hands-on role with the potential to grow into a broader systems leadership function as the company scales. Location: Brisbane, CA (onsite).

Responsibilities

• Business partnership
  • Serve as primary IT partner to Clinical Operations, Regulatory, Quality, and Commercial
  • Translate business needs into system requirements and implementation plans
  • Own stakeholder satisfaction for the enterprise applications portfolio
  • Proactively identify technology opportunities that enable business outcomes
• Application portfolio management
  • Own the clinical, quality, regulatory, and commercial application portfolio
  • Current systems: Medidata Rave (EDC), Wingspan eTMF, Argus (pharmacovigilance), Veeva Vault RIM (submissions), Veeva CRM, Veeva QMS, VeevaDocs, Veeva Training
  • ERP/back-office systems as commercial operations expand
  • Define application roadmap aligned to clinical milestones and commercial readiness
  • Manage system integrations, data flows, and reporting needs
• Implementation and delivery
  • Lead implementations end-to-end: requirements, configuration, testing, training, go-live
  • Coordinate with clinical PM contractor on project execution
  • Align with IT Project Manager on resource conflicts, shared vendors, and portfolio reporting
  • Manage UAT coordination, training development, and change management
• Vendor management
  • Own functional relationships with application vendors (what gets built, does it work, is it adopted)
  • Partner with Director, IT Strategy & Vendor Operations on contracts, SOWs, and vendor governance
  • Hold vendors accountable for delivery outcomes and service quality
  • Ensure vendors build internal capability, not dependency
• Compliance and quality
  • Partner with Quality on GxP validation requirements for regulated systems
  • Understand CSV principles; work alongside Qualitas and internal validation resources
  • Support FDA inspection readiness for IT-related controls
  • Ensure 21 CFR Part 11 compliance for electronic records and signatures

Qualifications

• Required: 10+ years in IT, with 5+ years in life sciences or pharmaceutical environments
• Required: Direct experience with clinical systems: EDC, eTMF, CTMS, safety/PV, or regulatory submissions
• Required: Veeva platform experience (Vault, CRM, QMS)
• Required: Medidata Rave experience
• Required: Track record leading application implementations from requirements through adoption
• Required: Experience managing vendors for delivery outcomes (not just contract administration)
• Required: Working knowledge of GxP validation principles and 21 CFR Part 11
• Required: Strong business analyst skills: requirements gathering, process design, stakeholder facilitation
• Required: Comfortable with hands-on configuration and troubleshooting when needed
• Required: Effective communicator with scientific, clinical, and business audiences
• Required: Bachelor's degree in a technical field, or equivalent experience
• Preferred: Experience supporting regulatory submissions or FDA inspection readiness
• Preferred: Commercial systems experience (CRM, market access, patient services)
• Preferred: ERP implementation or administration experience

Education

• Bachelor's degree in a technical field, or equivalent experience