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Director, Clinical Quality

Viking Therapeutics, Inc. • San Diego, CA, US • published 2026-10-23 02:05:07.168424

Description

Description: The Director, Clinical Quality will lead the Clinical Quality Assurance function and provide strategic leadership and hands\-on quality oversight across early\- through late\-stage clinical development programs. The role is responsible for developing, implementing, and maintaining phase\-appropriate, risk\-based GCP quality systems, processes, and governance that support reliable clinical data, protection of clinical trial participants, and advancement of clinical programs toward regulatory submissions and inspections. The Director will partner closely with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other cross\-functional stakeholders and will provide independent Quality oversight of contract research organizations (CROs), clinical sites, laboratories, and other GCP service providers. The role will lead GCP inspection readiness, clinical quality risk management, audit strategy, significant quality issue management, and continuous improvement activities supporting late\-stage development and NDA/BIMO readiness. The successful candidate will be a pragmatic, collaborative Clinical Quality leader who can establish ...

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