Associate Director of Clinical Development & Pharmacovigilance
Akero TherapeuticsSan Francisco, California, United States
Posted September 9, 2025
165000 - 175000 USD year
Full Time
About the Company
Akero Therapeutics is a clinical-stage biotech company focused on developing innovative treatments for serious metabolic diseases like MASH. Their lead product candidate, EFX, is currently being tested in multiple Phase 2b and Phase 3 clinical trials for patients with cirrhosis or pre-cirrhotic conditions due to MASH. Headquartered in South San Francisco, Akero aims to address high unmet medical needs through cutting-edge research and development.
Job Description
Akero Therapeutics is seeking a Quality Assurance (QA) Representative to provide quality oversight and compliance support for Clinical Development and Pharmacovigilance (PV) activities. This role will ensure adherence to Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, supporting regulatory submissions and safeguarding patient rights. The QA Representative will collaborate with clinical, regulatory, and CRO teams to deliver high-quality execution of clinical and safety activities.
Requirements
- Bachelor’s or advanced degree in Life Sciences, Biotechnology, Pharmacy, or related field
- Minimum of 10 years of experience in Quality Assurance within Clinical Operations and/or Pharmacovigilance, preferably in biologics or biotechnology
- Strong knowledge of global regulatory requirements: ICH-GCP, EU GCP Directive/Regulation, FDA GCP regulations, and international GVP standards
- Experience with CRO and PV vendor oversight, including audits and inspections
- Familiarity with electronic systems for clinical and safety data
- Demonstrated success in managing quality issues, audits, and regulatory inspections
Benefits
- Competitive salary
- Special Advisory
