Director, Regulatory Submissions Lead — Cross-Functional PM

Kite Pharma; Thousand Oaks (CA); On-site; USD 205,000 - 290,000; Full time

Job summary

Kite Pharma seeks a Director of Submission Project Management to lead strategic planning and execution of major regulatory submissions globally. You will coordinate clinical data readiness, cross-functional teams, and governance to ensure timely, compliant filings.

Prerequisites include a doctorate, extensive regulatory expertise, and strong leadership across Development, Regulatory, and Quality functions. Bay Area base with competitive compensation and broad benefits.

Qualifications

• Doctorate, Master’s, or Bachelor’s degree plus relevant pharmaceutical/biotech experience.
• Extensive regulatory submission experience including BLAs, NDAs, and global filings.
• Strong leadership of cross-functional teams without direct reporting authority.
• PM certifications (PMP) and process-improvement credentials are preferred.

Responsibilities

• Lead end-to-end regulatory submission strategy and execution across major filings.
• Coordinate cross-functional development, biometrics, regulatory, and governance activities.
• Drive on-time delivery of clinical data readiness and submission components.
• Develop governance, milestones, and risk-mitigation plans for regulatory programs.
• Mentor and develop submission management capabilities across teams.

Skills

People leadership

Regulatory submission experience

Cross-functional collaboration

Project management

Education

Doctorate

Master's

Bachelor's

Tools

PMP certification

Lean Six Sigma

Job description

Kite Pharma seeks a Director of Submission Project Management to lead strategic planning and execution of major regulatory submissions globally. You will coordinate clinical data readiness, cross-functional teams, and governance to ensure timely, compliant filings.

Prerequisites include a doctorate, extensive regulatory expertise, and strong leadership across Development, Regulatory, and Quality functions. Bay Area base with competitive compensation and broad benefits.