Senior Director, Clinical Quality Assurance (CQA)

4D Molecular Therapeutics

9d•$245,000 - $286,000

About The Position

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.

Requirements

Bachelor's degree in a life science, nursing, pharmacy, or related field; advanced degree (MS, PharmD, PhD) preferred.
12+ years of experience or advanced degree with 10+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar Industry
Proven experience leading Clinical quality strategy, quality governance, and senior-level quality oversight of global clinical trials and associated vendors
Minimum of 7 years of significant experience in clinical quality assurance, including experience leading, performing, and/or providing senior oversight of GCP audits and global clinical trials.
Experience hosting, leading, and supporting health authority inspections, including inspection readiness preparation, front-room/back-room support, response coordination, and follow-up commitment management
Extensive practical experience and understanding of clinical quality assurance applied throughout the clinical development life-cycle
Demonstrated ability to influence senior cross-functional stakeholders, lead complex clinical quality initiatives, and provide mentorship or functional leadership within Clinical QA
Expert understanding of GCP requirements for investigational products and the ability to interpret and apply requirements strategically across clinical programs
Executive-level communication skills, both oral and written, with ability to present quality risks, recommendations, and inspection-readiness status to senior stakeholders
Strong leadership, influencing, and interpersonal skills, with a collaborative approach to driving alignment across Clinical, Quality, Regulatory, and external vendor stakeholders
Demonstrated ability to operate independently in a fast-paced small company environment, prioritize complex workstreams, make risk-based decisions with minimal direction, and adjust quickly to changing business priorities

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 decision-making.
Provide QA oversight for formal corrective and preventive actions (CAPAs), ensuring actions are risk-based, effective, timely, and appropriately escalated to address identified Clinical Study Quality Events, including potential serious breaches of GCP.
Partner with CMC Quality, Clinical Operations, and senior cross-functional stakeholders to facilitate the investigation, escalation, and resolution of clinical supply quality issues such as temperature excursions, product complaints, and deviations reported from clinical sites, ensuring appropriate risk assessment, stakeholder communication, and CAPA linkage when applicable.
Champion and advance a culture of quality that fosters learning, respect, open communication, collaboration, integration, and teamwork:
Oversee and provide strategic direction for development of GCP compliance training materials and delivery of training to strengthen clinical quality culture and inspection readiness.
Partner with Clinical Operations, Clinical Development, Biometrics, Data Management, Medical Affairs, and Regulatory Affairs to embed proactive quality and risk management into study design and conduct.
Lead the development and continuous improvement of the Clinical Quality Management system through the development / refinement of Clinical QA processes
Lead preparedness / readiness / management of BIMO / GCP inspections:
Define and lead GCP inspection readiness strategy, plans, and cross-functional readiness activities, including readiness governance, mock inspection support, inspection logistics, and issue escalation
Host, lead, and/or provide senior Quality support for GCP-related inspections