Senior Program Manager; Pharma

Currently partnering with a global public biopharmaceutical company seeking a Senior Program Manager with a strong background in lyophilized small-molecule products and extensive experience managing cross-functional programs across Clinical, Nonclinical, Regulatory, and CMC functions.

As a Senior Program Manager, you will oversee end-to-end program execution, ensuring alignment between development teams, regulatory strategy, and manufacturing. You will act as the central point of accountability for program deliverables, timelines, and regulatory readiness, playing a key role in moving programs toward IND and NDA submissions and ultimately commercial launch.

• Lead cross-functional program management for small-molecule development, including Clinical, Nonclinical, Regulatory, and CMC functions
• Oversee lyophilized drug product programs, ensuring integration of formulation, manufacturing, and regulatory requirements
• Drive regulatory filings, including INDs, NDAs, and supporting documentation, collaborating closely with regulatory and CMC teams
• Track program timelines, manage risks and dependencies, and report progress to senior leadership
• Ensure document management and compliance, maintaining program records, regulatory files, and submission-ready documentation
• Support resource planning and team coordination, optimizing program execution and efficiency

• Bachelor’s or advanced degree in relevant field
• Strong small-molecule development experience, with a focus on lyophilized products
• Proven experience with regulatory filings, including INDs and NDAs
• Significant program-level experience across Clinical, Nonclinical, Regulatory, and CMC functions
• Strong project/program management skills, including document management, timelines, and risk tracking
• Ability to coordinate cross-functional teams and drive programs to key milestones

Apply today or reach out directly -