Associate Director, CMC Lead

Associate Director leading chemistry, manufacturing, and controls strategy for early-stage alpha-emitting radioconjugate programs. Will develop IND-enabling plans, coordinate API and drug product development, and manage clinical supply strategies across a portfolio of oncology candidates.

Responsibilities

• Define and deliver pharmaceutical development strategy for pre-IND portfolio to drive first-in-human readiness
• Lead CMC regulatory strategy and author IND/IMPD documentation and data packages
• Coordinate API, drug product, and analytical development to establish scalable, robust processes
• Build clinical supply strategies for Phase 0/I aligned with isotope availability and study timelines
• Manage portfolio priorities and risk assessments across multiple early-stage programs

Requirements

• 7+ years pharmaceutical or biopharmaceutical product development and manufacturing experience
• Bachelor's degree; advanced degree in chemistry, pharmaceutics, or chemical engineering preferred
• Demonstrated CMC development experience including IND-enabling activities and analytical method development
• Strong project leadership managing multiple concurrent early-stage programs
• Cross-functional collaboration and stakeholder influence skills across matrix organization
• Phase-appropriate pharmaceutical strategy development across API, drug product, and analytical areas
• Problem-solving ability in data-limited, ambiguous early-stage environments

Compensation: $136,514–$204,771 USD base annual