Director Project Management, Commercial & Medical Affairs

Direct Hire/Full – Time

Redwood City

$220,000 - $250,000

A biopharmaceutical organization focused on developing innovative treatments for rare diseases is seeking a highly motivated Project Manager at the Director level. This role will provide expert project management support for a new drug application submission and other critical cross-functional programs involving Clinical, Regulatory, CMC, Commercial, and Medical Affairs teams, ensuring alignment with the organization's strategic objectives.

Responsibilities

• Develop and upkeep comprehensive project plans to meet objectives on time and within budget.
• For key meetings (e.g., project team or partner meetings), create agendas, lead discussions, document minutes, track decisions, issues, and action items.
• Ensure timely resolution of action items through diligent follow-up.
• Compile, monitor, and maintain program progress reports and present updates to internal stakeholders.
• Assist Finance in creating program budgets, tracking actuals against forecasts, and identifying areas for resource optimization or significant deviations.
• Review critical documents to ensure alignment with program and project goals.
• Coordinate internal resources, contract manufacturing organizations, contract research organizations, and vendors/suppliers to ensure seamless project execution.
• Provide strategic project management support across Commercial functions, including Marketing, Sales, Operations, and Market Access.
• Oversee and support key Medical Affairs initiatives to ensure alignment and execution of objectives.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• Over 10 years of experience in pharmaceutical project management, including late-stage Clinical, Regulatory, and CMC development through commercialization.
• PMP certification is highly desirable but not mandatory.
• Thrives in a fast-paced, collaborative environment while remaining flexible, proactive, resourceful, and efficient.
• Exceptional interpersonal skills with the ability to build strong relationships with key stakeholders.
• Strong conflict management and negotiation abilities.
• Proven ability to analyze complex issues and develop practical, realistic plans, programs, and recommendations.
• Demonstrated skill in translating strategy into actionable plans, with strong analytical abilities and the capacity to communicate complex issues clearly and resolve risks effectively.
• Excellent organizational, facilitation, and presentation skills.
• Proven ability to manage complex projects with adaptability to shifting priorities and timelines.