Sr. R&D IT Manager

4D Molecular Therapeutics

Location
Emeryville, California
Employment type
unknown
Posted
Posted
  • 331000 - IT Enterprise

About the role

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration and the second indication is diabetic macular edema, which are both in Phase 3 development. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together: Dare to Cure Break Boundaries Beyond Yourself Prepare & Execute Relentlessly Join us in creating the future of genetic medicine. GENERAL SUMMARY 4D Molecular Therapeutics (4DMT) is a late-stage clinical gene therapy company advancing a potentially transformative pipeline toward its first Biologics License Application (BLA) and commercial launch. 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 4DMT organizations, including R&D, Technical Operations, Clinical Science and Operations, Data Sciences and Biostatistics, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Pharmacovigilance, Program Management, Facilities, and Medical Affairs. The role is accountable for the technical ownership, implementation, administration, integration, operation, security, support, inspection readiness, and lifecycle of an assigned group of systems. The Sr. Manager 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. This is a hands-on IT role requiring a balanced combination of technical knowledge, GxP system lifecycle experience, and project leadership. The Sr. Manager applies independent judgment to resolve complex system-level issues, leads interdependent technical and compliance workstreams, provides senior-level guidance for assigned applications, and supports the appropriate use of automation and approved AI technologies. The role operates within the strategy established by IT leadership. 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, and translate them into technology requirements, solution options, and recommendations. Partner with Quality Assurance and IT Computer System Validation to determine GxP applicability, system risk, validation strategy, required controls, testing approach, and lifecycle documentation while 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 the authorized IT scope. Understand and 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 are established and maintained for electronic records and signatures, access, audit trails, data integrity, integrations, data migration, backup and recovery, retention, archival, change management, and vendor oversight. Serve 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, and support audits, regulatory inspections, supplier assessments, periodic reviews, deviations, CAPAs, and remediation activities for assigned systems. Lead and manage contractors, consultants, managed-service providers, and vendor resources supporting assigned systems and projects. Establish priorities, deliverables, acceptance criteria, service expectations, and escalation paths; review performance and work quality; and ensure outsourced deliverables meet applicable technical, security, validation, documentation, and GxP requirements. Develop and manage lifecycle roadmaps for assigned applications and recommend upgrades, replacements, integrations, support-model improvements, and retirement. Identify appropriate opportunities to use workflow automation, low-code platforms, data tools, scripting, Microsoft Copilot, and other approved AI technologies to improve business processes and system operations. Lead cross-functional teams and mentor colleagues and system stakeholders in IT System Owner practices, application governance, validation partnership, operational support, inspection readiness, and vendor oversight. Communicate system health, project status, risks, technical options, and investment needs to stakeholders, and escalate material portfolio, architecture, compliance, funding, security, and resource decisions to IT leadership Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time QUALIFICATIONS: Education: <span data-ccp-props="{"201341

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