Head, Project Management & Program Management

Role Summary

Head of Project Management & Program Management, reporting to the Chief Business & Strategy Officer, will lead the project management office (PMO) responsible for cross-functional strategic and operational execution of ivonescimab development through regulatory approval and commercialization. They will drive cross-functional alignment, ensuring delivery of clinical development plans from Phase I through Phase III, and supporting regulatory filings including BLA, MAA, and other global submissions. Location: on-site in Miami, FL, or Princeton, NJ, or Menlo Park, CA.

Responsibilities

• Lead a high-performing Project Management Office that supports strategic planning and execution across all development programs.
• Oversee & define the integrated program plan covering Phase I-III trials and regulatory filings
• Lead cross-functional teams including Clinical, Regulatory, Medical Affairs, CMC, Operations, and Commercial to align on strategy, resolve issues, and drive execution.
• Oversee planning and execution of multiple clinical trials, ensuring readiness for regulatory filings and inspection preparedness.
• Facilitate decision-making processes, including risk mitigation strategies, plan amendments, and scenario planning.
• Present updates, risks, and strategic recommendations to the Executive Leadership Team and other senior stakeholders regarding ivonescimab.
• Mentor and develop project managers and program leads, fostering a culture of accountability, innovation, and continuous improvement.
• Driving strategic alignment for development, research, manufacturing, regulatory, medical affairs, market access, pricing and commercialization plans
• All other duties as assigned

Qualifications

• Advanced Degree (Ph.D., M.D., Pharm.D., MBA, or applicable master’s degree) with at least 15+ years of pharmaceutical / biotech industry experience, including leadership experience in program management or similar function, is required.
• Proven leadership in project management and program management across Phase I-III clinical trials.
• Experience in cross-functional team leadership, including strategy development and driving tactical delivery of programs.
• Strong experience in drug development and late-stage registration required, oncology experience strongly preferred.
• Deep understanding of regulatory pathways and commercialization strategies.

Skills

• Exceptional communication, negotiation, and stakeholder management skills.