Director, Global Pre-Approval Patient Access

Responsibilities

• Develop and implement a global early access strategy aligned with clinical and regulatory milestones
• Design and execute named-patient and cohort early access programs globally at no cost
• Lead cross-functional collaboration across Clinical, Regulatory, Medical Affairs, and Commercial teams
• Establish governance for evaluating and prioritizing new early access programs globally
• Oversee all operational aspects of programs, including vendor management
• Create policies and frameworks for ethical access decisions while ensuring compliance with regulations
• Partner with Development to align early access planning with product lifecycle strategy

Qualifications

• Bachelor's degree in a healthcare field; advanced degree preferred
• Minimum of 8 years of experience in clinical trial operations and Oncology early access in biotech/pharmaceutical
• Proven track record in designing and executing global early access programs
• Strong understanding of key regulatory authorities and their timelines
• Excellent organizational skills, with a proactive and creative approach to problem-solving
• Demonstrated ability to manage large cross-functional teams effectively
• Strong relationship management skills within the biotech/pharmaceutical industry

Benefits

• Robust equity awards and competitive cash compensation
• Strong benefits package that supports employee wellbeing
• Significant learning and development opportunities for career growth