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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) and commercial launch. Reporting to the Sr. Director, IT Business Partner, R&D, the Sr. R&D IT Manager, provides hands-on technology leadership and serves as the IT System Owner for assigned GxP and business-critical applications and initiatives supporting 4DMT organizations, including R&D, Technical Operations, Clinical Science and Operations, Data Sciences and Biostatistics, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Pharmacovigilance, Program Management, Facilities, and Medical Affairs.
The role is accountable for the technical ownership, implementation, administration, integration, operation, security, support, inspection readiness, and lifecycle of an assigned group of systems. The Sr. Manager partners with Business Process Owners, QA, IT Computer System Validation (CSV), IT infrastructure teams, vendors, and implementation partners to ensure systems are fit for intended use, appropriately validated, reliable, secure, and supportable.
This is a hands-on IT role requiring a balanced combination of technical knowledge, GxP system lifecycle experience, and project leadership. The Sr. Manager applies independent judgment to resolve complex system-level issues, leads interdependent technical and compliance workstreams, provides senior-level guidance for assigned applications, and supports the appropriate use of automation and approved AI technologies. The role operates within the strategy established by IT leadership.
MAJOR DUTIES & RESPONSIBILITIES:- Serve as the IT System Owner for an assigned group of GxP and business-critical applications, including laboratory systems such as LIMS, chromatography data systems, laboratory instrument software, and scientific data platforms, with accountability for technical health, regulatory readiness, operational performance, supportability, and lifecycle outcomes.
- Partner with Business Process Owners to understand intended use, business processes, operational priorities, and user needs, and translate them into technology requirements, solution options, and recommendations.
- Partner with Quality Assurance and IT Computer System Validation to determine GxP applicability, system risk, validation strategy, required controls, testing approach, and lifecycle documentation while maintaining appropriate role independence.
- Lead complex system implementations, upgrades, integrations, migrations, remediation activities, and technology-enabled process improvements from evaluation through validated deployment and operational transition. Manage scope, schedule, risks, dependencies, approved budgets, and cross-functional workstreams.
- Administer or oversee application configuration, user accounts, security roles, interfaces, reports, scheduled processes, reference data, and other technical components within the authorized IT scope.
- Understand and maintain appropriate documentation of application architecture, hosting models, integrations, data flows, technical dependencies, identity and access controls, backup and recovery, business continuity, and vendor support arrangements.
- Ensure appropriate controls are established and maintained for electronic records and signatures, access, audit trails, data integrity, integrations, data migration, backup and recovery, retention, archival, change management, and vendor oversight.
- Serve as the senior IT escalation point for complex application, validation, integration, performance, instrument-interface, data-integrity, and vendor-performance issues, leading root-cause analysis and sustainable resolution.
- Maintain inspection-ready technical, validation, operational, and lifecycle documentation, and support audits, regulatory inspections, supplier assessments, periodic reviews, deviations, CAPAs, and remediation activities for assigned systems.
- Lead and manage contractors, consultants, managed-service providers, and vendor resources supporting assigned systems and projects. Establish priorities, deliverables, acceptance criteria, service expectations, and escalation paths; review performance and work quality; and ensure outsourced deliverables meet applicable technical, security, validation, documentation, and GxP requirements.
- Develop and manage lifecycle roadmaps for assigned applications and recommend upgrades, replacements, integrations, support-model improvements, and retirement. Identify appropriate opportunities to use workflow automation, low-code platforms, data tools, scripting, Microsoft Copilot, and other approved AI technologies to improve business processes and system operations.
- Lead cross-functional teams and mentor colleagues and system stakeholders in IT System Owner practices, application governance, validation partnership, operational support, inspection readiness, and vendor oversight.
- Communicate system health, project status, risks, technical options, and investment needs to stakeholders, and escalate material portfolio, architecture, compliance, funding, security, and resource decisions to IT leadership
- Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time
QUALIFICATIONS:Education:
- Bachelor's degree in Computer Science, Information Systems, Software Engineering, or a related technical discipline
- Advanced degree or relevant professional certification is preferred
Experience:
- 8+ years of progressive experience with a Bachelor's degree or 6+ years with a Master's degree, supporting, implementing, administering, validating, and managing business applications in a pharmaceutical, medical-device, or comparable regulated environment.
- Hands-on experience serving as the IT System Owner, application owner, system administrator, technical lead, product owner, or comparable role for multiple regulated or business-critical applications.
- Experience with the full lifecycle of GxP computerized systems, including requirements, implementation, validation, deployment, change control, operational support, periodic review, upgrades, and retirement.
- Demonstrated experience leading complex GxP technology initiatives involving multiple business, technical, quality, validation, security, integration, and vendor stakeholders.
- Experience collaborating with Business Process Owners, QA, CSV, IT infrastructure teams, vendors, and implementation partners, and making system-level risk and lifecycle recommendations.
- Experience with GxP systems and interfaces, IT QA, or Computer System Validation is strongly preferred.
- Demonstrated experience directing contractors, consultants, implementation partners, or managed-service resources, including setting priorities, reviewing deliverables, monitoring performance, resolving delivery issues, and ensuring technical quality and compliance.
Other Qualifications/Skills:
- Strong understanding of IT System Owner responsibilities and GxP computerized system controls, including 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ principles, and risk-based Computer Software Assurance practices.
- Ability to quickly understand application architecture, integrations, data flows, hosting models, security controls, technical dependencies, and support requirements.
- Ability to balance business needs, compliance requirements, technical risks, operational support, security, and cost when making system-level recommendations.
- Strong project leadership, technical problem-solving, vendor management, documentation, and stakeholder communication skills.
- Working knowledge of programming, scripting, databases, workflow automation, or low-code technology sufficient to evaluate solution designs, vendor approaches, and automated solutions is preferred.
- Experience using Microsoft Copilot or other approved artificial-intelligence tools to improve productivity, documentation, information management, or business processes is preferred.
Travel: N/A
Physical Requirements and Working Conditions:
- 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: $135,000 - $150,000
Please 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.
