[Hiring] Senior Director, Clinical Quality Assurance @4D Molecular Therapeutics

Role Description

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.
• Lead the development, implementation, and governance of Clinical Study Quality Plans for specific 4DMT clinical studies.
• 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.
• Ensure audit findings, quality risks, and CAPA commitments are communicated to senior stakeholders.
• Provide senior Quality review and strategic input on Clinical documents, ensuring quality, accuracy, completeness, and inspection readiness of key clinical and regulatory documents.
• Lead and/or provide oversight for investigation and management of significant Clinical Study Quality Events.
• Provide QA oversight for formal corrective and preventive actions (CAPAs).
• Partner with CMC Quality, Clinical Operations, and senior cross-functional stakeholders to facilitate the investigation, escalation, and resolution of clinical supply quality issues.
• 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.
• Lead the development and continuous improvement of the Clinical Quality Management system.
• Define and lead GCP inspection readiness strategy, plans, and cross-functional readiness activities.

Qualifications

• 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.
• Experience hosting, leading, and supporting health authority inspections.
• Extensive practical experience and understanding of clinical quality assurance applied throughout the clinical development life-cycle.
• Demonstrated ability to influence senior cross-functional stakeholders.

Requirements

• Expert understanding of GCP requirements for investigational products.
• Executive-level communication skills, both oral and written.
• Strong leadership, influencing, and interpersonal skills.
• Demonstrated ability to operate independently in a fast-paced small company environment.

Benefits

• Base salary compensation range: $245,000 - 286,000.
• Actual salary offered depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Company Description

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.

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.