4D Molecular Therapeutics · 16 hours ago
Clinical Technology Manager, IT
4DMT is a leading late-stage biotechnology company focused on advancing durable and disease-targeted therapeutics. The Clinical Technology Manager, IT is responsible for the strategy, delivery, and operational integrity of information systems supporting the Clinical Research and Development organization, ensuring compliance and efficient execution of clinical systems.
BiotechnologyGenetics
Responsibilities
Own and operate clinical systems as system owner, including access control, configuration, validation, and lifecycle management
Ensure systems remain compliant with GxP regulations and internal SOPs, preserving data integrity and inspection readiness
Lead requirements definition, solution design, and implementation planning with cross-functional stakeholders
Provide Level-2 application support and vendor coordination for incident resolution and system enhancements
Maintain and continuously improve system documentation, including validation deliverables, SOPs, and operational records
Partner with Clinical Data Management to support data quality, flow, and operational needs
Execute core system governance activities, including performance monitoring, upgrades, disaster recovery testing, access reviews, and license and vendor management
Drive system adoption through training, documentation, and user enablement
Support audits and regulatory inspections, including inspection responses, remediation, and CAPA closure
Contribute to product roadmaps and release planning, balancing business value, regulatory risk, and technical feasibility
Manage and maintain collaborative relationships with core business partners
Qualification
Required
8–12+ years of experience implementing and operating technology solutions supporting clinical research and development
Proven experience across the CSV lifecycle, including validation, production deployment, support, and decommissioning
Strong working knowledge of FDA and EMA regulations, including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR
Broad technical fluency across applications, infrastructure, cloud platforms, integrations, and operations
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related discipline (or equivalent experience)
Preferred
Collaboration with Clinical Data Management and Biometrics teams
Experience with Medidata Rave, SAS (Grid, Viya, 9.4), Spotfire, and Veeva TMF and RIM
Experience operating systems in Google Cloud environments
Strong vendor management and service governance experience
Experience with product road mapping, KPIs, and SLAs aligned to clinical priorities
Exposure to low-code platforms and applied AI in clinical research
Company
4D Molecular Therapeutics
4D Molecular Therapeutics designs, develops, and commercializes transformative gene therapeutic products for unmet medical conditions.
H1B Sponsorship
4D Molecular Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$702.5MKey Investors
Cystic Fibrosis FoundationViking Global Investors
2025-11-06Post Ipo Equity· $100M
2025-10-13Post Ipo Equity· $7.5M
2024-02-06Post Ipo Equity· $300M
Recent News
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2025-12-19
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2025-12-19
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