Associate Director of Clinical Development & Pharmacovigilance

Associate Director Of Clinical Development & Pharmacovigilance

Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Job Summary

The Quality Assurance (QA) Representative will provide quality oversight and compliance support for Clinical Development and Pharmacovigilance (PV) activities related to biologic development programs. This individual will be responsible for ensuring that clinical trial execution, safety reporting, and pharmacovigilance systems meet Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, as well as all applicable global regulatory standards. The QA Representative will partner closely with Clinical, Pharmacovigilance, Regulatory Affairs, and external service providers to ensure high-quality execution of clinical and safety activities that safeguard patient rights, safety, and data integrity.

Job Responsibilities

Clinical Operations Oversight

• Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs.
• Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50 / 54 / 56 / 312, EMA regulations, and other international clinical trial requirements.
• Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams.
• Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations.

Pharmacovigilance Oversight

Quality Systems & Compliance

Cross-Functional & External Collaboration

Qualifications

Compensation

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