Attention 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 biologics (aflibercept and anti-VEGF-C) with a single 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 and the second indication is diabetic macular edema, which are both in Phase 3 development. 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.

We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together:

Dare to Cure
Break Boundaries
Beyond Yourself
Prepare & Execute Relentlessly

Join us in creating the future of genetic medicine.

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.