Director, Program Management (Clinical Development / Regs / Quality)
I’m partnering with a commercial-stage biotech entering a pivotal growth phase following recent regulatory and corporate milestones.
They are seeking a Director, Program Management to work closely with executive leadership and drive cross-functional program execution across Clinical Development and key partnering functions.
The Role
- Lead integrated cross-functional project plans spanning Clinical Development, Clinical Operations, Regulatory, Technical Operations/CMC, and Commercial
- Support lifecycle management and potential new indications
- Drive execution aligned with corporate strategy and board-level priorities
- Facilitate governance meetings and senior leadership updates
- Maintain risk registers, dashboards, and executive reporting tools
- Coordinate CROs, CMOs, and external vendors
- Support launch readiness and post-approval initiatives
This is a highly visible, strategic role with significant organizational influence.
Requirements
- 10+ years of pharmaceutical/biotech project management experience
- Strong knowledge of the drug development lifecycle through commercialization
- Experience operating in small-to-mid size biotech environments
- Proven ability to translate strategy into execution
- PMP preferred
- Strong executive communication and cross-functional leadership skills