United States onlyAttention 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:
The Clinical Technology, IT professional is the accountable owner for the strategy, delivery, and operational integrity of information systems supporting 4DMT’s Clinical Research and Development organization. This role ensures clinical systems are fit for purpose, inspection-ready, and maintained in a validated state, while advancing technology solutions that enable efficient, compliant clinical execution.
The position serves as the primary liaison between Clinical R&D, Data Management, IT, and external vendors, driving alignment, governance, and disciplined system ownership across the full lifecycle—from design and implementation through operation and retirement.
MAJOR DUTIES & 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.
QUALIFICATIONS:
- 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 Experience:
- 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.
Base salary compensation range: $110,000 - $150,000
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