Director, IT Business Partner, R&D

About this 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 (aflibercept and anti-VEGF-C) with a single, safe, 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, which is currently in Phase 3 development, and second indication is diabetic macular edema. 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

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.

Success will be measured by stakeholder satisfaction; delivery of assigned roadmap commitments on schedule & within budget; inspection, submission, manufacturing, supply & launch readiness; availability, adoption & validated-state performance of assigned platforms; effective risk, vendor & financial management; & measurable business value from compliant data, analytics, automation & AI.

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 within the strategy, architecture, investment priorities & governance established by the Sr. Director.

• Lead vendors, contractors & cross-functional project teams for assigned initiatives, setting clear deliverables, coordinating resources, resolving delivery issues & escalating material risks or decisions to the Sr. Director.

• 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, translating approved direction into executable plans.

• 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 ahead of the rolling BLA submission.

• Manage assigned technology & data initiatives supporting 4DMT’s transition to a commercial organization across Regulatory Affairs, Pharmacovigilance, Medical Affairs, TechOps, Supply Management, Quality & Facilities, aligned to topline data, BLA, technology transfer, PDUFA & launch milestones.

• 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, partnering with scientists, lab leaders & IT infrastructure to protect availability, cybersecurity, data integrity & chain of custody.

• 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 integrated with enterprise, quality, laboratory & financial platforms.

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