Director, Clinical Quality Assurance (CQA)

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 (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 Director of Clinical Quality Assurance (CQA) will be responsible for Quality Assurance oversight of multiple, global, 4DMT sponsored clinical trials, ensuring trials are executed in compliance with all applicable international regulatory requirements for Good Clinical Practice (GCP). This position reports to the Senior Director, GCP Compliance and Quality Systems and contributes to the development, implementation, and successful execution of the CQA mission, objectives, and strategic plan. MAJOR DUTIES & RESPONSIBILITIES: Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities: Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies, focused on ensuring subject safety/rights, study data integrity, and GCP compliance. Provide guidance and support to clinical study teams, including via attendance at Study team meetings and via investigation and management of Clinical Study Quality Events Ensure principles of Risk Management are applied to the Clinical Study per ICH E6 Identify, communicate, and escalate significant incidents of GCP non-compliance and follow to resolution, acting at all times with an appropriate sense of urgency Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs Perform Clinical Document reviews, ensuring the quality, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries Support investigation and management of specific Clinical Study Quality Events as assigned: Monitor, track, and facilitate the completion of formal corrective and preventive actions (CAPAs) to address identified Clinical Study Quality Events, including potential serious breaches of GCP. Support a quality-focused work environment in Clinical that fosters learning, respect, open communication, collaboration, integration, and teamwork: Work with Clinical stakeholders to develop GCP compliance training materials and conduct training Partner with Clinical team to review, update and maintain related SOPs, identify the need for new SOPs, and support the review of new SOPs as needed Work with Clinical stakeholders to support Training, Development, and Implementation of 4DMT Clinical Study Risk Management Process/Tools to ensure principles of Risk Management are applied