Full-Time

Associate Director

Clinical Quality Assurance

Confirmed live in the last 24 hours

4D Molecular Therapeutics

4D Molecular Therapeutics

201-500 employees

Develops gene therapies for genetic diseases

Biotechnology
Healthcare

Compensation Overview

$152k - $199kAnnually

Senior

Oakland, CA, USA

Category
QA & Testing
Quality Assurance
Required Skills
Google Cloud Platform
Requirements
  • B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred.
  • 8+ 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, audit support, and quality oversight of global clinical studies, including knowledge of quality investigation / root cause analysis techniques
  • Minimum of 4 years of experience in a role including responsibility for providing GCP oversight of clinical study activities, preferably at a clinical study sponsor
  • 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
  • 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.
Responsibilities
  • Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities:
  • Partner with Clinical stakeholder to support timely identification, escalation, investigation, documentation, and resolution of GCP-related quality events, acting at all times with an appropriate sense of urgency.
  • Provide GCP guidance to clinical study teams, including via attendance at Study team meetings, with support from Sr. Director GCP Compliance.
  • Ensure principles of Risk Management are applied to Clinical Studies per ICH E6
  • Coordinate 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
  • 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
  • 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:
  • Drive the development and continuous improvement of the Clinical Quality Management System through the development / refinement of Clinical QA processes / initiatives as assigned
  • 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.
4D Molecular Therapeutics

4D Molecular Therapeutics

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4D Molecular Therapeutics develops gene therapies aimed at treating serious genetic diseases by delivering specific genetic material to patients' cells. The company utilizes a unique technology called "Therapeutic Vector Evolution" to create adeno-associated virus (AAV) vectors, which act as delivery vehicles for therapeutic genes targeting affected cells in the body. Unlike many competitors, 4DMT focuses on precision medicine for genetic disorders, including cystic fibrosis, and operates in a specialized biopharmaceutical market. Their goal is to advance their gene therapies through rigorous research, clinical trials, and partnerships, ultimately bringing effective treatments to patients.

Company Stage

IPO

Total Funding

$170.2M

Headquarters

Emeryville, California

Founded

2013

Growth & Insights
Headcount

6 month growth

18%

1 year growth

44%

2 year growth

76%
Simplify Jobs

Simplify's Take

What believers are saying

  • 4DMT secured a $962 million deal with Astellas Pharma for R100 vector technology.
  • Positive interim data from 4D-710 trials shows promise for cystic fibrosis treatment.
  • Lifting of clinical hold on 4D-310 suggests a clearer regulatory path for Fabry therapy.

What critics are saying

  • Public offering may dilute shareholder equity, affecting stock value.
  • Analysts cutting estimates could indicate potential financial underperformance.
  • Reliance on partnerships like Astellas exposes 4DMT to potential risks.

What makes 4D Molecular Therapeutics unique

  • 4DMT uses proprietary Therapeutic Vector Evolution for advanced AAV vector creation.
  • Their R100 vector technology effectively penetrates the internal limiting membrane in eye therapies.
  • 4DMT focuses on gene therapies for serious genetic diseases like cystic fibrosis and Fabry disease.

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