Director, IT Business Partner, R&D
Core
Deputy to Sr. Director, IT Business Partner, R&D, translating integrated R&D technology strategy into delivery across clinical, regulatory, safety, laboratory, manufacturing, and supply systems for pivotal development and BLA submission.
Role type
Senior IC IT Business Partner (R&D)
Builds
Validated GxP systems, data platforms, and technology roadmaps for late-stage biotech R&D and commercial launch
Domain
Biotechnology / Life Sciences / Regulated GxP
Required skills
GxP compliance, Computer System Validation (CSV), 21 CFR Part 11, vendor management, cross-functional project leadership, data governance, AI governance in regulated environments, supply chain technology, laboratory informatics
Preferred skills
Experience with BLA submission readiness, Argus safety systems, ELN/LIMS, CMMS, serialization, and responsible AI implementation
Technologies
Veeva RIM, Peer, Argus, ELN, LIMS, NGS, chromatography systems, CMMS, serialization platforms
Responsibilities
Lead vendors and cross-functional project teams for assigned initiatives; Represent IT in GxP inspections and regulatory audits; Manage assigned technology and data initiatives for commercial transition; Implement unified R&D data strategy and responsible AI use; Support TechOps and Supply Management technology roadmap; Manage R&D technology vendors and managed service providers
Seniority
Senior, hands-on IC