Sr. Manager, Clinical Oversight Monitoring

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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 Sr. Manager, Clinical Oversight Monitoring (COM Sr. Mgr.) supports the Associate Director, Monitoring Oversight Management, in executing the clinical oversight program across 4DMT studies. This role is responsible for ensuring that clinical monitoring activities performed by CROs and contract monitors align with Clinical Monitoring Plans, study protocols, and ICH/GCP requirements. The Sr. Mgr. will drive consistency in monitoring oversight practices, manage day-to-day execution of oversight tools and processes, and contribute to maintaining inspection readiness and monitoring quality across global programs.

MAJOR DUTIES & RESPONSIBILITIES:  

• Execute oversight activities in alignment with the Clinical Oversight Monitoring Plan and related SOPs.
• Partner with the Associate Director to refine and implement oversight tools, trackers, and metrics dashboards.
• Conduct quality control (QC) review of monitoring visit reports and follow-up letters to assess completeness, accuracy, and compliance with monitoring expectations.
• Track visit scheduling, report completion metrics, protocol deviations, and issue resolution to identify trends and risks across CRO, monitor, and site levels.
• Support the development and maintenance of monitoring oversight dashboards and performance metrics (e.g., timeliness, completeness, issue closure, out-of-window visits).
• Assist in implementation of risk-based oversight elements such as key risk indicators (KRIs), key performance indicators (KPIs), and quality tolerance limits (QTLs).
• Collaborate cross-functionally with Clinical Operations, Quality Assurance, and Data Management to ensure consistency in monitoring-related communications, escalation pathways, and issue management.
• Support vendor oversight by reviewing CRO performance reports, contributing to issue escalation, and tracking CAPA progress.
• Participate in inspection readiness activities, document reviews, and process audits to ensure oversight documentation is accurate and current.
• Assist in process improvement initiatives by analyzing oversight data and identifying areas for refinement or standardization.
• Maintain oversight documentation, trackers, and archives to ensure audit and inspection preparedness.
• Support onboarding and training of new COM team members and vendor associates on oversight tools and processes.
• Travel as required (estimated up to 20%).
• Other duties as assigned. Management reserves the right to adjust responsibilities as business needs evolve.

QUALIFICATIONS: 

Education: 

• A./B.S. degree in related Life Sciences discipline required
• Equivalent combination of education and applicable job experience may be considered.

Experience: 

• A./B.S. with 7+ years of experience in clinical monitoring or oversight roles.
• Hands-on experience in clinical monitoring, including review of monitoring visit reports and vendor deliverables.
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Experience supporting risk-based monitoring (RBM) and quality metrics programs.
• Demonstrated ability to review, interpret, and analyze monitoring data and reports.
• Familiarity with vendor oversight processes, including KPI tracking and issue managemen