Director, Clinical Quality Assurance (CQA)

4D Molecular Therapeutics

10h•Onsite

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. 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.

Requirements

S./B.A. degree in a science or related life science field or equivalent
10+ years of experience or advanced degree with 7+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar Industry
Proven experience with GCP Quality Management Systems, quality support, and quality oversight of global clinical trials
Minimum of 4 years of significant experience in clinical quality assurance, including experience performing/supporting GCP audits and overseeing global clinical trials, including in APAC.
Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life-cycle
In-depth understanding of GCP requirements for investigational products
Excellent communication skills, both oral and written
Excellent interpersonal skills, collaborative approach essential
Comfortable in a fast-paced small company environment with minimal direction and able to adjust to workload based upon changing priorities

Nice To Haves

advanced scientific degree preferred
5+ years of management experience or other specific work experience

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 to 4DMT Clinical Studies per ICH E6.
Drive the development and continuous improvement of the Clinical Quality Management System through the development / refinement of Clinical QA processes.
Support preparedness / readiness / management of BIMO inspections:
Develop/support GCP inspectional readiness plans and lead inspectional readiness activities.
Host and/or assist with management of GCP-related inspections.
Partner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.