Drug Development Project Manager

Job Title: Drug Development Project Manager
Location: Princeton NJ

Key Responsibilities:

• Lead end-to-end project management for drug development programs across preclinical, clinical, regulatory, and commercialization phases.
• Develop and maintain detailed project plans, timelines, milestones, budgets, and risk mitigation strategies.
• Coordinate cross-functional teams including Clinical, Regulatory Affairs, CMC, Quality, Medical Affairs, and Commercial teams.
• Track project deliverables and ensure alignment with business goals and regulatory requirements.
• Identify project risks, issues, and dependencies; proactively drive mitigation plans.
• Facilitate governance meetings, prepare project status reports, and communicate updates to leadership.
• Support IND, NDA, BLA submissions and other regulatory milestones.
• Ensure compliance with GxP, FDA, and global regulatory standards.
• Manage vendor relationships and external partnerships as needed.

Required Qualifications:

• Bachelor s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• 8+ years of project management experience in pharmaceutical, biotech, or drug development environments.
• Strong knowledge of drug development lifecycle from discovery to commercialization.
• Experience managing clinical development, regulatory submissions, and cross-functional teams.
• Strong understanding of FDA regulations, GxP, and industry standards.
• Excellent communication, leadership, and stakeholder management skills.
• Experience with project management tools such as MS Project, Smartsheet, or Jira.