Description

As the Medical Affairs Late Phase Program Manager, you will provide Clinical Operations oversight for Phase 4 and post-marketing studies, ensuring alignment with regulatory requirements and managing vendor, drug supply, and financial activities. You'll serve as the primary sponsor representative, driving trial execution and inspection readiness in support of patients with RAS-addicted cancers.

Requirements

• Strong expertise in late-phase clinical research and post-marketing studies
• Solid understanding of Clinical Operations, GCP, and FDA regulatory requirements
• Oncology experience preferred
• Experience in vendor oversight and financial management of clinical studies
• Ability to ensure Trial Master File inspection readiness

Responsibilities

• Serve as sponsor lead for Phase 4 and post-marketing studies, overseeing start-up, conduct, amendments, and close-out
• Ensure sponsor responsibilities under FDA regulations, ICH guidelines, and GCP are fulfilled
• Oversee external vendors delivering late-phase clinical services, monitoring performance against scope, timelines, and budget
• Partner with Regulatory, Medical Affairs, Safety, and Supply Chain for post-marketing commitments and drug supply governance
• Manage risk by tracking milestones, operational risks, and proactively escalating issues