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GENERAL SUMMARY4D 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.
- 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, applying the approved risk-scaled framework with model validation, human review & traceability.
- 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 for backup & recovery, role-based security, user provisioning, audit trails, data transfer & archival meet 21 CFR Part 11, Annex 11 & applicable 4DMT procedures for assigned platforms.
- Provide assigned technology support for Medical Affairs field & launch-readiness capabilities, including medical content management & Medical, Legal & Regulatory review through Veeva PromoMats, until ownership transitions to the Sr. Director, Commercial IT Business Partner.
- 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.
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range:
$208,000 - $242,000Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
