Director, Clinical Quality Assurance - Gcp Compliance

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

 

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

Position Summary:   

The Director of Clinical Quality Assurance (CQA) will be responsible for Quality Assurance oversight of multiple 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.  

*Proven experience providing Clinical Quality/GCP Compliance oversight for a sponsor conducting registrational studies.*

Essential 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 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. 

QUALIFICATIONS:  

• B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred. 
• 10+ years working 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 for a sponsor conducting registrational studies, 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  
• In-depth understanding of GCP requirements for investigational products  
• Extensive practical experience and understanding of Clinical Quality Assurance as applied throughout the clinical development life-cycle  
• (Optional) 5+ years of management experience or other specific work experience  
• 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 workload based upon changing priorities 

BASE SALARY COMPENSATION RANGE:

Bay Area-based candidates: $217,000/yr. - $240,000/yr.

National Range: $182,000/yr. - $220,000/yr. 

Please note that compensation varies based on a variety of factors including experience, location, etc.

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