Clinical Technology Manager, IT
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Job Location:
Emeryville, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Attention recruitment agencies: All agency inquiries are vetted through 4DMTs 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 Companys 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 Companys 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 Companys 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 is the accountable owner for the strategy delivery and operational integrity of information systems supporting 4DMTs 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 lifecyclefrom 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:
- 812 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.
- Bachelors 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: $103000 - $140000
Required Experience:
Manager
Key Skills
- Computer Hardware
- IT Experience
- IT Management
- Network Installation
- Vendor Management
- Computer Networking
- Microsoft Windows Server
- Windows
- IT Service Management
- ITIL
- SAN
- Network Architecture
About Company
4D Molecular Therapeutics designs, develops and commercializes transformative gene therapeutic products for serious unmet medical conditions.
