Clinical Technology Manager

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.

• 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.

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, 4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our "disease first" approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease. At 4DMT we are creating and developing optimized "biopharmaceutical grade" AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration. At 4DMT we use our robust discovery platform, termed "Therapeutic Vector Evolution," to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo. 4D Purpose Statement: Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients GUIDING PRINCIPLES * Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them * Break Boundaries - Question the status quo and innovate beyond conventional approaches * Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other. * Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development.