--- title: 'Senior Director, Clinical Quality Assurance (CQA) at 4D Molecular Therapeutics' canonical: 'https://feeny.ai/job/senior-director-clinical-quality-assurance-cqa-4d-molecular-therapeutics-united-xhe4n9jrfe00' type: 'job' last_seen: '2026-09-13' --- # Senior Director, Clinical Quality Assurance (CQA) at 4D Molecular Therapeutics - **Company:** 4D Molecular Therapeutics - **Location:** United States - **Work type:** remote - **Posted:** 2026-08-31 - **Last confirmed live:** 2026-09-13 - **Apply:** https://4dmoleculartherapeutics.com/careers/?gh_jid=4729038005 ## Job description 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 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 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 ## QUALIFICATIONS: Education: - Bachelor's degree in a life science, nursing, pharmacy, or related field; advanced degree (MS, PharmD, PhD) preferred. - Experience in Ophthalmology is highly desired Experience: - 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 Other Qualifications/Skills: - 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 Travel: %5 Physical Requirements and Working Conditions: - Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. - Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met. - Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Base salary compensation range: $245,000 - 286,000 Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities ## About 4D Molecular Therapeutics ## Company Overview - **One-liner**: 4D Molecular Therapeutics is a late-stage clinical biotechnology company inventing and developing customized genetic medicines using a proprietary vector evolution platform to treat large-market diseases. - **Entity Type**: Public (NASDAQ: FDMT) - **Headquarters**: Emeryville, California, United States - **Founded**: 2013 - **Founders**: David Kirn, MD (Co-Founder, President, and CEO) ## Core Business - **Primary industry**: Biotechnology / Genetic Medicine / Gene Therapy - **Target customers**: B2B (partnerships with other biopharma companies) and B2C (patients with retinal and pulmonary diseases) - **Mission or purpose statement**: "To unlock the full potential of genetic medicines for large market diseases" by harnessing directed evolution to invent customized and enhanced vectors for transformative products. ## Products & Services - **4D-150**: A clinical-stage genetic medicine candidate for retinal vascular diseases (wet age-related macular degeneration and diabetic macular edema). It is designed as a single, routine, low-dose intravitreal injection that provides multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C). Currently in Phase 3 clinical trials (4FRONT-1 and 4FRONT-2) for wet AMD and Phase 1/2 for DME. - **4D-710**: An investigational genetic medicine candidate for cystic fibrosis lung disease. It uses the A101 vector for aerosol delivery of a corrective CFTR transgene (CFTR∆R) and is designed for patients ineligible for or who have discontinued CFTR modulator therapy. Currently in Phase 1/2. - **4D-175**: A preclinical candidate for geographic atrophy (a form of dry AMD) using the R100 vector to deliver a shortened form of human complement factor H (sCFH) to restore normal complement regulation. - **4D-725**: A preclinical candidate for alpha-1 antitrypsin (A1AT) lung disease using the A101 vector for aerosol delivery. ## Market Standing - **Valuation/Market Cap**: $756.4 million (as of latest data from LinkedIn) - **Key Metric**: Annual Revenue of $85.2 million (as of latest data from LinkedIn) - **Notable Investors/Partners**: The company is publicly traded (IPO in 2020). Key partnerships are sought for pipeline candidates like 4D-175 and 4D-725. - **Growth Signals**: The company is a late-stage biotech with two Phase 3 trials (4FRONT-1 and 4FRONT-2) for its lead candidate 4D-150 in wet AMD, and a Phase 1/2 trial for 4D-710 in cystic fibrosis. The company has a presence in Ecuador, France, and India. LinkedIn followers grew 24.7% year-over-year. ## Competitive Advantages - **Proprietary Vector Platform (Therapeutic Vector Evolution)**: The company uses directed evolution to create customized and proprietary AAV vectors (e.g., R100 for retina, A101 for lung) that are optimized for specific tissues and routes of administration, which is a significant differentiator from standard gene therapy approaches. - **Large-Market Focus**: Unlike many gene therapy companies targeting ultra-rare diseases, 4DMT is focused on large-market indications (wet AMD, DME, cystic fibrosis) with high unmet need, offering a potentially massive commercial opportunity. - **Durable, Single-Dose Therapies**: Their products are designed to provide multi-year efficacy from a single injection, which could dramatically reduce treatment burden for patients compared to current standard-of-care (e.g., frequent eye injections for wet AMD). ## Strategic Focus - **Advancing Late-Stage Pipeline**: The primary focus is executing the Phase 3 programs for 4D-150 in wet AMD and progressing 4D-710 in cystic fibrosis. - **Expanding Indications**: The company is exploring 4D-150 for diabetic macular edema (DME) and seeking partnerships to advance 4D-175 (geographic atrophy) and 4D-725 (A1AT deficiency). - **Platform Expansion**: Continuing to leverage the Therapeutic Vector Evolution platform to develop new genetic medicines for other large-market diseases. ## Why Work Here - **Mission-Driven Culture**: The company is deeply committed to "daring to cure" and unlocking the potential of genetic medicine for patients with devastating diseases. Core values include "Dare to Cure," "Break Boundaries," "Prepare & Execute Relentlessly," and "Beyond Yourself." - **Innovative Science**: Employees work on cutting-edge science at the intersection of gene therapy, vector engineering, and clinical development, tackling some of the biggest challenges in medicine. - **Collaborative Environment**: The company emphasizes teamwork, internal and external collaboration, and a culture that empowers innovation. - **Location & Perks**: Based in Emeryville, CA (San Francisco Bay Area). The company offers a competitive benefits package and a dynamic, collaborative environment. - **Diversity & Inclusion**: 4DMT champions diversity, equity, and inclusion through an employee-led initiative called "4Diversity," which partners with charitable organizations and focuses on social equity. - **Work Authorization**: Candidates must be authorized to work in the U.S. The company does not sponsor new nonimmigrant visa status petitions but welcomes candidates who require transfers or extensions. ## Sources 1. [4dmoleculartherapeutics.com](https://4dmoleculartherapeutics.com/) 2. [4dmoleculartherapeutics.com - About](https://4dmoleculartherapeutics.com/about/) 3. [4dmoleculartherapeutics.com - Careers](https://4dmoleculartherapeutics.com/careers/) 4. [4dmoleculartherapeutics.com - Pipeline](https://4dmoleculartherapeutics.com/pipeline/) 5. 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