Full-Time

Associate Director

Clinical Quality Assurance

Posted on 10/30/2024

4D Molecular Therapeutics

4D Molecular Therapeutics

201-500 employees

Develops gene therapies for genetic diseases

Biotechnology
Healthcare

Compensation Overview

$152k - $199kAnnually

Senior, Expert

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 specific cells in the body. Unlike many competitors, 4DMT focuses on precision medicine for genetic disorders, including cystic fibrosis, and operates in the specialized biopharmaceutical market. Their goal is to conduct thorough research and clinical trials to ensure the safety and effectiveness of their therapies, ultimately commercializing them through direct sales or partnerships with larger pharmaceutical companies.

Company Stage

IPO

Total Funding

$170.2M

Headquarters

Emeryville, California

Founded

2013

Growth & Insights
Headcount

6 month growth

18%

1 year growth

42%

2 year growth

77%
Simplify Jobs

Simplify's Take

What believers are saying

  • Positive interim data from 4D-710 trial suggests promising efficacy for cystic fibrosis.
  • Strategic partnership with Astellas could provide significant financial resources and validation.
  • Recent $75 million Series C financing supports growth and development initiatives.

What critics are saying

  • Potential competition from other biotech companies could impact market share.
  • High cost of clinical trials may lead to financial strain if results are unfavorable.
  • Regulatory challenges could delay approval processes for new gene therapies.

What makes 4D Molecular Therapeutics unique

  • 4DMT uses proprietary Therapeutic Vector Evolution for advanced AAV vector creation.
  • Their R100 vector technology overcomes challenges in eye-directed gene therapies.
  • 4DMT focuses on precision medicine for serious genetic diseases like cystic fibrosis.

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