Tech Stack

Description

You will lead integrated CMC program planning and execution across clinical development stages, translating CMC strategy into actionable plans. Collaborating with cross-functional teams and external partners, you'll drive accountability, manage risk, and support regulatory submissions.

Requirements

• Bachelor's degree required, Life Sciences preferred
• Proficiency in MS Office, Smartsheet, and collaboration platforms
• Knowledge of CMC development processes across clinical stages
• Familiarity with regulatory submission timelines and CMC documentation preferred

Responsibilities

• Lead integrated CMC planning across DS, DP, AC, QA, RA, and SC
• Build and maintain integrated project timelines in Smartsheet
• Identify program risks and drive mitigation planning
• Facilitate CMC sub-team meetings and document decisions
• Prepare leadership-ready status updates and track key metrics
• Support regulatory submission readiness
• Partner with Technical Operations and CDMOs for coordinated execution
• Strengthen CMC program management practices and tools
• Provide program-level budget visibility and tracking
• Contribute to a collaborative culture