Senior Director, Clinical Quality Assurance (CQA)

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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 Senior Director of Clinical Quality Assurance (CQA) will provide strategic and operational Quality Assurance leadership and oversight for multiple, registrational, global 4DMT -sponsored clinical trials, ensuring trials are executed in compliance with applicable international regulatory requirements for Good Clinical Practice (GCP).

This position reports to the Executive Director, Quality Assurance and is accountable for advancing the CQA mission, objectives, and strategic plan through proactive quality strategy, risk-based oversight, inspection readiness, and continuous improvement of clinical quality systems.

MAJOR DUTIES & RESPONSIBILITIES:

Provide strategic Quality leadership and oversight for multiple 4DMT Clinical Studies, including the following study-specific activities:

- Serve as a senior Quality partner to clinical study teams and leadership, providing guidance on GCP, ICH E6, and related regulations and guidance,, decision support, and escalation recommendations, including via attendance at Study team meetings, quality governance forums, and escalation discussions related to Clinical Study Quality Events.

- Lead the development, implementation, and governance of Clinical Study Quality Plans for specific 4DMT clinical studies, with accountability for protecting subject safety/rights, data integrity, and GCP compliance across assigned studies and associated vendors.

- Manage, mentor, and develop Clinical QA staff and consultants; establish clear goals, development plans, and succession depth.

- Define, plan, perform, and/or oversee risk-based GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites

- Ensure audit findings, quality risks, and CAPA commitments are communicated to senior stakeholders and collaborate with auditees and vendors to track, review, approve, assess the adequacy of CAPAs, and ensure timely escalation of unresolved or recurring issues

- Provide senior Quality review and strategic input on Clinical documents, ensuring quality, accuracy, completeness, and inspection readiness of key clinical and regulatory documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 and 2.7 Tabulated and Written Summaries, and Integrated Summaries.

Lead and/or provide oversight for investigation and management of significant Clinical Study Quality Events:

- Identify, communicate, and escalate significant incidents of GCP non-compliance, quality risks, and inspection-readiness concerns, and drive timely resolution, ensuring appropriate executive visibility, escalation, and risk-based d