Director Information Technology, Development Operations

• 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 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.

Qualifications :

• Bachelors or Masters 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.

Preferred Experience:

• 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).

Additional Information :

The anticipated salary range for candidates who will work in our San Diego location is between  $200000-$250000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc. 

ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristics.

Remote Work :

No

Employment Type :

Full-time