Director, IT Business Partner, R&D

4D Molecular Therapeutics•Emeryville, CA

4d•$208,000 - $242,000

About The Position

4D Molecular Therapeutics (4DMT) is a late-stage clinical gene therapy company advancing a pipeline toward its first Biologics License Application (BLA) and commercial launch. Reporting to the Sr. Director, IT Business Partner, R&D, the Director serves as a broad deputy across R&D and helps translate the integrated R&D technology strategy into delivery across clinical, regulatory, safety, laboratory, scientific informatics, manufacturing, supply, quality, and facilities systems, data, and integrations needed for pivotal development, BLA submission, inspection readiness, and launch. The role partners with PreClinical R&D, Technical Operations, Supply Management, Clinical Science and Operations, Data Sciences and Biostatistics, Quality, Regulatory Affairs, Pharmacovigilance, Program Management, Facilities, and Medical Affairs. The Director manages assigned platforms, initiatives, and workstreams; coordinates vendors, contractors, and project teams; and connects functional needs to the integrated R&D roadmap across the research-to-commercial lifecycle. Success is measured by stakeholder satisfaction; on-time and on-budget delivery; inspection, submission, manufacturing, supply, and launch readiness; platform availability, adoption, and validated-state performance; effective risk, vendor, and financial management; and measurable business value from compliant data, analytics, automation, and AI.

Requirements

BS/BA required; a technical, scientific, engineering, information systems, or computer science major is preferred.
13+ years of progressive experience in IT, digital, clinical technology, laboratory informatics, or manufacturing/quality technology roles in biotechnology, pharmaceutical, or another regulated life sciences environment.
8+ years leading R&D applications, business partnerships, and GxP technology operations.
3+ years leading vendors, contractors, technical contributors, and cross-functional project teams across multiple R&D functions.
Experience supporting R&D systems and data through at least one Phase 3 clinical trial, one regulatory inspection, multiple regulatory submissions, and a technology transfer or other major regulated operational milestone.
Deep experience applying risk-based system assurance, SDLC, change control, access management, supplier oversight, cybersecurity, and data-integrity practices.
Working knowledge of 21 CFR Part 11, EU Annex 11, ICH E6(R3), GAMP 5, cGMP, ALCOA+, and relevant data standards such as IDMP.
Deep understanding of Research/PreClinical, Clinical, Regulatory Affairs, Pharmacovigilance, TechOps, Supply Management, Quality, and Facilities business processes across the research-to-commercial lifecycle.
Strong working knowledge of regulated R&D platforms, including CTMS, EDC, eTMF, eCOA/ePRO, IRT, statistical computing, RIM, safety, ELN, LIMS, scientific data, ERP, planning, warehouse, quality management, document and learning management, CMMS, calibration, environmental, and building management systems.
Ability to identify, evaluate, and deploy AI solutions with business, IT, Quality, Security, and AI governance stakeholders to maximize value and compliant use in regulated workflows.
Strong knowledge of enterprise and scientific data architecture, instrument connectivity, IT operations, cybersecurity, portfolio and project management, continuous improvement, and organizational change management.
Strong senior-stakeholder partnership, influence, and communication skills, including translating between business and technology audiences, making clear recommendations, and working effectively with senior scientific, clinical, and operations leaders.
Accountable, responsive, self-driven, and able to operate independently within established strategy, governance, and decision rights, with timely escalation of material risks, tradeoffs, and decisions.
Able to contribute to a positive culture and thrive within a high-growth, fast-paced, small but growing company.

Nice To Haves

MS/MA preferred.
Veeva Vault Platform Administrator or relevant laboratory informatics, quality, supply chain, or project-management certification is a plus.
Experience with Veeva Vault, SAS, Spotfire, Argus, PeerAI, Sapio, Benchling, ACE, ComplianceWire, NetSuite, Blue Mountain, M365 Copilot, or comparable platforms is preferred.

Responsibilities

Serve as a broad deputy to the Sr. Director, IT Business Partner, R&D, execute the integrated R&D technology strategy, and represent R&D IT in assigned forums, initiatives, and escalations.
Act as IT business partner and system owner for assigned R&D platforms, accountable for roadmap execution, implementation, integrations, validated-state maintenance, service performance, security, data integrity, adoption, and lifecycle planning within established strategy and governance.
Lead vendors, contractors, and cross-functional project teams for assigned initiatives; set deliverables, coordinate resources, resolve delivery issues, and escalate material risks or decisions.
Partner with functional leaders, IT Council members, Security, Finance, and Procurement to manage demand intake, develop business cases, recommend priorities, plan resources, oversee delivery, track benefits, and prepare portfolio reporting.
Contribute to R&D systems and data architecture and roadmap planning aligned with Phase 3, BLA, PDUFA, inspection, technology transfer, external manufacturing, commercial-readiness, and operational-resilience objectives.
Represent IT for assigned systems and workstreams in GxP inspections, regulatory audits, and internal quality reviews, ensuring ownership, validation evidence, access controls, audit trails, vendor oversight, and data-integrity documentation are ready and defensible.
Lead assigned BLA submission-readiness workstreams with Regulatory Affairs, ensuring submission publishing and archival platforms, including Peer and Veeva RIM, are validated, optimized, and inspection-ready ahead of the rolling BLA submission.
Manage assigned technology and data initiatives supporting the transition to a commercial organization across Regulatory Affairs, Pharmacovigilance, Medical Affairs, TechOps, Supply Management, Quality, and Facilities.
Manage assigned safety technology capabilities for the transition from clinical to post-marketing safety operations, including Argus, signal detection, case intake and adverse-event adjudication, and social media safety monitoring.
Manage assigned laboratory systems and scientific informatics capabilities, including ELN, LIMS, scientific data platforms, instrument software, chromatography and analytical systems, imaging, NGS, sample and inventory management, and instrument connectivity.
Support execution of the TechOps and Supply Management technology roadmap through assigned manufacturing, materials, inventory, planning, supplier, cold-chain, serialization, warehouse, logistics, external partner, and product-traceability initiatives.
Support execution of the Quality technology roadmap through assigned quality and document management, training, deviations, CAPA, change control, complaints, supplier quality, audits, and inspection-management initiatives.
Partner with Facilities and Engineering on assigned technology for building management, environmental monitoring, maintenance management (CMMS), calibration, metrology, asset management, physical access, alarms, and critical facility operations.
Help implement the unified R&D data strategy across clinical, scientific, manufacturing, and quality data, including governance, metadata, master data, FAIR principles, retention, archival, and reuse for analytics and AI-enabled decision support.
Partner with the AI Governance Council and Quality to implement responsible, validated, and auditable AI use in assigned regulated GxP, laboratory, and manufacturing workflows, applying the approved risk-scaled framework with model validation, human review, and traceability.
Manage assigned R&D technology vendors and managed service providers, including contracts, budgets, forecasts, service levels, performance metrics, escalation, validation obligations, security, data protection, business continuity, exit planning, and periodic risk reviews.
Apply Computer System Validation, Computer Software Assurance, and SDLC procedures using a risk-based, fit-for-purpose approach, ensuring assigned platform controls meet 21 CFR Part 11, Annex 11, and applicable 4DMT procedures.
Provide assigned technology support for Medical Affairs field and launch-readiness capabilities, including medical content management and Medical, Legal, and Regulatory review through Veeva PromoMats, until ownership transitions to the Sr. Director, Commercial IT Business Partner.
Maintain operational excellence and drive continuous improvement for assigned services, staying current on clinical technology, laboratory informatics, manufacturing, supply chain, quality, data management, AI, and life sciences best practices.