Head, Project Management & Program Management

Role Summary

Head, Project Management & Program Management will lead the project management office (PMO) responsible for cross-functional strategic and operational execution of development and ultimate regulatory approval and commercialization of ivonescimab. They will drive cross-functional alignment, ensure delivery of clinical development plans from Phase I through Phase III, and support regulatory filings including BLA, MAA, and other global submissions. The Head is accountable for establishing and maintaining an integrated project plan covering all aspects of the ivonescimab development program(s), including clinical development, regulatory, biometrics, clinical operations, medical affairs, CMC/manufacturing, and commercial. This leader will shape and oversee the function, build best-in-class PM practices, secure resources, mentor a team, and foster partnerships with internal teams and external collaborators to maximize portfolio value. Location: On-site in Miami, FL - Menlo Park, CA - or Princeton, NJ.

Responsibilities

• Lead a high-performing Project Management Office that supports strategic planning and execution across all development programs.
• Oversee and 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.
• Drive 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 a similar function.
• 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 regulatory registration; oncology experience strongly preferred.
• Deep understanding of regulatory pathways and commercialization strategies.
• Exceptional communication, negotiation, and stakeholder management skills.

Skills

• Strategic planning and execution
• Cross-functional leadership
• Regulatory filings and compliance
• Risk management and scenario planning
• Mentoring and building high-performing teams

Education

• Advanced degree as specified in Qualifications.

Additional Requirements

• Location: On-site in Miami, FL - or Menlo Park, CA - or Princeton, NJ.