Description

You will support Olema Oncology's clinical studies by ensuring clinical quality, GCP adherence, and inspection readiness. You'll collaborate cross-functionally to provide compliance guidance, drive best practices, and improve processes for compliant clinical study execution.

Requirements

• Bachelor's Degree
• 7+ years in pharmaceutical/biotech industry (sponsor and/or CRO)
• 5+ years in compliance, GCP function, or clinical project leadership
• Experience managing multiple projects and prioritizing in fast-paced environment
• Knowledge of global clinical trial execution and drug development process

Responsibilities

• Build and maintain fit-for-purpose clinical compliance processes aligned with ICH-GCP and global regulations
• Partner with Clinical Operations to embed quality-by-design principles throughout study lifecycle
• Provide hands-on compliance guidance, identify risks, and drive mitigation strategies
• Lead root cause analysis and development of Quality Events/CAPAs
• Support inspection readiness activities with KPIs, storyboards, and regulatory preparation