Director, IT Business Partner, R&D

The role

The Director serves as a deputy to the Sr. Director, IT Business Partner, R&D to execute the integrated R&D technology strategy. This person manages assigned platforms, coordinates vendors and project teams, and connects functional needs to the R&D roadmap across the research-to-commercial lifecycle.

What you will do

• Serve as a broad deputy to the Sr. Director, IT Business Partner, R&D
• Serve as IT business partner and system owner for assigned R&D platforms
• Lead vendors, contractors and cross-functional project teams
• Partner with R&D, TechOps, Quality and Facilities leaders to manage demand and resources
• Contribute to R&D systems and data architecture and roadmap
• Represent IT for assigned systems in GxP inspections and regulatory audits
• Lead assigned BLA submission-readiness workstreams
• Manage assigned technology and data initiatives for transition to a commercial organization
• Manage assigned safety technology capabilities
• Manage assigned laboratory systems and scientific informatics capabilities

Required qualifications

• BS/BA required
• 13+ years of progressive experience in IT, digital, clinical technology, laboratory informatics or manufacturing/quality technology roles in biotechnology, pharmaceutical or another regulated life sci
• 8+ years leading R&D applications, business partnerships and GxP technology operations
• 3+ years leading vendors, contractors, technical contributors and cross-functional project teams
• 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 op
• 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
• 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 managem
• Strong knowledge of enterprise and scientific data architecture, instrument connectivity, IT operations, cybersecurity, portfolio and project management, continuous improvement and organizational chan
• Strong senior-stakeholder partnership, influence and communication skills
• Repetitive motions of the wrists, hands, and/or fingers

Nice to have

• technical, scientific, engineering, information systems or computer science major
• MS/MA
• Veeva Vault Platform Administrator or relevant laboratory informatics, quality, supply chain or project-management certification
• Experience with Veeva Vault, SAS, Spotfire, Argus, PeerAI, Sapio, Benchling, ACE, ComplianceWire, NetSuite, Blue Mountain, M365 Copilot or comparable platforms

About the company

4D Molecular Therapeutics (4DMT) is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company is a late-stage clinical gene therapy company advancing a potentially transformative pipeline toward its first Biologics License Application (BLA) and commercial launch.