Global Phase 3 Clinical Ops Director - Hybrid

Maze Therapeutics, Inc.; South San Francisco (CA); Sur place; USD 232 000 - 283 000; Plein temps

Résumé du poste

Maze Therapeutics in the San Francisco Bay Area seeks a Director of Clinical Operations to lead a global pivotal Phase 3 program in chronic kidney disease. You will translate development strategy into executable plans, oversee a cross‑functional study team, and ensure quality, speed, and inspection readiness across the study lifecycle.

You will manage CROs, vendors, and the internal study execution team, driving risk management, data integrity, and regulatory compliance while aligning resources

Qualifications

• Bachelor’s degree in a scientific or health‑related field.
• 10–12+ years of clinical operations experience, including study leadership of Phase I–III trials.
• Demonstrated success as the end‑to‑end operational lead for a complex large global Phase 3 study.

Responsabilités

• Lead global Phase 3 study execution from protocol development through enrollment, database lock, and inspection readiness.
• Oversee CRO, vendor, and site strategies with governance, performance metrics, and risk management.
• Maintain accountability for a large global study budget including forecasting and variance analysis.
• Ensure data quality, regulatory readiness, and adherence to SOPs, ICH‑GCP, and global regulatory requirements.
• Collaborate with QA and Oversight Director on compliance strategy and continuous improvement.

Connaissances

Clinical operations leadership

Budget management

Cross-functional collaboration

Regulatory knowledge

Vendor management

Team development

Formation

Bachelor's degree in scientific/health field

Outils

GCP/compliance tools

TMF management

CRO governance

Description du poste

Maze Therapeutics in the San Francisco Bay Area seeks a Director of Clinical Operations to lead a global pivotal Phase 3 program in chronic kidney disease. You will translate development strategy into executable plans, oversee a cross‑functional study team, and ensure quality, speed, and inspection readiness across the study lifecycle.

You will manage CROs, vendors, and the internal study execution team, driving risk management, data integrity, and regulatory compliance while aligning resources