Director Information Technology, Development Operations
About The Position
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com , and follow us on X or LinkedIn . 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
- IT Business Partnership & Strategy 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.
- System Ownership & Implementation 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.
- Compliance & Validation 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.
- Inspection Readiness & Support Partner with QA and Regulatory to prepare for health authority inspections.
- Provide IT support during inspections, including system demonstrations and documentation.
- Project & Change Management Lead cross-functional projects from concept through deployment.
- Manage change control processes and ensure stakeholder alignment.
- Manage the UAT planning, execution, and reporting.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
