Director, IT Business Partner, R&D

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) & commercial launch. Reporting to the Sr. Director, IT Business Partner, R&D, the Director serves as a broad deputy across R&D & helps translate the integrated R&D technology strategy into delivery across clinical, regulatory, safety, laboratory, scientific informatics, manufacturing, supply, quality & facility systems, data & integrations required for pivotal development, BLA submission, inspection readiness & launch.

This role partners across PreClinical R&D, Technical Operations (including Supply Management), Clinical Science & Operations, Data Sciences & Biostatistics, Quality, Regulatory Affairs, Pharmacovigilance, Program Management, Facilities & Medical Affairs. The Director supports the objectives of the Sr. Director by managing assigned platforms, initiatives & workstreams; coordinating vendors, contractors & project teams; & connecting functional needs to the integrated R&D roadmap across the research-to-commercial lifecycle.

Major Duties & Responsibilities

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

Qualifications

Education: BS/BA required, with a technical, scientific, engineering, information systems or computer science major preferred. MS/MA preferred. Veeva Vault Platform Administrator or relevant laboratory informatics, quality, supply chain or project-management certification a plus.

Experience: 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, including 8+ years leading R&D applications, business partnerships & GxP technology operations. 3+ years leading vendors, contractors, technical contributors & cross-functional project teams across multiple R&D functions. Experience supporting R&D systems & data through at least one Phase 3 clinical trial, one regulatory inspection, multiple regulatory submissions & a technology transfer or other major regulated operational milestone. Deep experience applying risk-based system assurance, SDLC, change control, access management, supplier oversight, cybersecurity & data-integrity practices, with working knowledge of 21 CFR Part 11, EU Annex 11, ICH E6(R3), GAMP 5, cGMP, ALCOA+ & relevant data standards such as IDMP.

Key Qualifications/Skills

• Deep understanding of Research/PreClinical, Clinical, Regulatory Affairs, Pharmacovigilance, TechOps, Supply Management, Quality & 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 & learning management, CMMS, calibration, environmental & building management systems.
• Experience with Veeva Vault, SAS, Spotfire, Argus, PeerAI, Sapio, Benchling, ACE, ComplianceWire, NetSuite, Blue Mountain, M365 Copilot or comparable platforms is preferred.
• Proven ability to identify, evaluate & deploy AI solutions with business, IT, Quality, Security & AI governance stakeholders to maximize value & compliant use in regulated workflows.
• Strong knowledge of enterprise & scientific data architecture, instrument connectivity, IT operations, cybersecurity, portfolio & project management, continuous improvement & organizational change management.
• Strong senior-stakeholder partnership, influence & communication skills, including the ability to translate between business & technology audiences, make clear recommendations & operate effectively with senior scientific, clinical & operations leaders.
• Contributes to a positive culture & thrives within a high-growth, fast-paced, small but growing company.
• Accountable, responsive, self-driven & able to operate independently within established strategy, governance & decision rights, with timely escalation of material risks, tradeoffs & decisions.