Senior Director Program Management

Role: Senior Director of Program Management overseeing late-stage clinical development through BLA submission. Responsibilities: lead integrated program planning, execution, and governance across functions such as Clinical, Regulatory, CMC, Safety, and Commercial; develop and maintain development plans, manage risks, dependencies, and resources; coordinate BLA-readiness activities, scenario planning, and stakeholder reporting; drive continuous improvement and leverage AI tools. Requirements: 15+ years in pharmaceutical/biotech development, with extensive experience in late-stage development and regulatory submissions (BLA preferred); strong leadership in cross-functional programs; deep understanding of FDA processes; excellent communication, risk management, and program governance skills; proficiency with project management tools; preferably experience in immunology, inflammatory diseases, dermatology, or atopic dermatitis. Qualifications: Bachelor’s degree in a relevant field, advanced degree and PMP or similar certification preferred. Work setup: primarily remote; travel may be required for meetings and regulatory activities.