Director Information Technology, Development Operations

Oric Pharmaceuticals, Inc.•San Diego, CA

32d•$200,000 - $250,000

About The Position

Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready.

Requirements

Bachelor's or Master's degree in Computer Science, Life Sciences, or related field.
8+ years of experience in IT supporting development functions in the biopharma industry.
Strong knowledge of Veeva Vault applications and their configuration.
Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance.
Familiarity with Phase 3 clinical trial operations and regulatory submission processes.
Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.).
Experience in R&D data domains and lifecycle.
Excellent communication, stakeholder management, and problem-solving skills.

Nice To Haves

Experience supporting global clinical trials and regulatory submissions.
Prior involvement in inspection readiness or direct participation in regulatory audits.
Knowledge of Quality Management Systems (QMS).

Responsibilities

Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs.
Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives.
Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS).
Gather application business requirements and systems goals from business owners and translate them into technical requirements.
Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo.
Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems.
Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11.
Lead the IT GDPR compliance program.
Own CSV documentation and audit readiness for IT-supported platforms.
Partner with QA and Regulatory to prepare for health authority inspections.
Provide IT support during inspections, including system demonstrations and documentation.
Lead cross-functional projects from concept through deployment.
Manage change control processes and ensure stakeholder alignment.
Manage the UAT planning, execution, and reporting.