Sr. R&D IT Manager
4Dmoleculartherapeutics · Emeryville, California
About this role
**Sr. R&D IT Manager** **About 4DMT** 4D Molecular Therapeutics (4DMT) is a late-stage biotechnology company advancing durable, disease-targeted therapeutics with the potential to transform treatment paradigms and provide unprecedented benefits to patients. **Role Overview** Reporting to the Sr. Director, IT Business Partner, R&D, the Sr. R&D IT Manager provides hands-on technology leadership and serves as the IT System Owner for assigned GxP and business-critical applications and initiatives supporting R&D, Technical Operations, Clinical Science and Operations, Data Sciences and Biostatistics, QA/QC, Regulatory Affairs, Pharmacovigilance, Program Management, Facilities, and Medical Affairs. This is a hands-on IT role accountable for technical ownership, implementation, administration, integration, operation, security, support, inspection readiness, and lifecycle management of an assigned group of systems. The role partners with Business Process Owners, QA, IT Computer System Validation (CSV), IT infrastructure teams, vendors, and implementation partners to ensure systems are fit for intended use, appropriately validated, reliable, secure, and supportable. **Major Duties & Responsibilities** - Serve as the IT System Owner for an assigned group of GxP and business-critical applications (including laboratory systems such as LIMS, chromatography data systems, laboratory instrument software, and scientific data platforms), with accountability for technical health, regulatory readiness, operational performance, supportability, and lifecycle outcomes. - Partner with Business Process Owners to understand intended use, business processes, operational priorities, and user needs—then translate them into technology requirements, solution options, and recommendations. - Partner with QA and IT CSV to determine GxP applicability, system risk, validation strategy, required controls, testing approach, and lifecycle documentation—maintaining appropriate role independence. - Lead complex system implementations, upgrades, integrations, migrations, remediation activities, and technology-enabled process improvements from evaluation through validated deployment and operational transition. Manage scope, schedule, risks, dependencies, approved budgets, and cross-functional workstreams. - Administer or oversee application configuration, user accounts, security roles, interfaces, reports, scheduled processes, reference data, and other technical components within authorized IT scope. - Maintain appropriate documentation of application architecture, hosting models, integrations, data flows, technical dependencies, identity and access controls, backup and recovery, business continuity, and vendor support arrangements. - Ensure appropriate controls for electronic records and signatures, access, audit trails, data integrity, integrations, data migration, backup and recovery, retention, archival, change management, and vendor oversight. - Act as the senior IT escalation point for complex application, validation, integration, performance, instrument-interface, data-integrity, and vendor-performance issues—leading root-cause analysis and sustainable resolution. - Maintain inspection-ready technical, validation, operational, and lifecycle documentation; support audits, regulatory inspections, supplier assessments, periodic reviews, deviations, CAPAs, and remediation activities for assigned systems. - Lead and manage contractors, consultants, managed-service providers
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