Clinical Quality Assurance Senior Leader
4 days ago
We are seeking a highly experienced Clinical Quality Assurance Sr. Director to join our team at Alumis.
In this role, you will work closely with Development leadership and Study Execution Team members to provide GCP/GVP support for all ongoing clinical studies.
This involves establishing Key Performance Indicators and Metrics to trend and track the health of clinical trials, as well as providing operational quality guidance for development teams.
About the Role
- Determine the strategy for and lead the implementation of inspection readiness plans and activities.
- Support clinical service provider selection and qualification activities.
- Manage Quality Review Board meetings content and material.
Requirements
- Expertise in FDA regulations and practices, ICH guidance, and global health authority regulations and practices.
- Hands-on experience in drug life cycle management.
- Prior management experience required.
Compensation and Benefits
The estimated salary for this position is $260,000 USD to $275,000 USD annually.
Alumis offers a competitive compensation package, including benefits such as generous stock option grants and an annual bonus program.
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