Senior Director of Drug Development

Job Summary

Providing strategic and operational leadership, the full-time Senior Director of Drug Development will oversee the development, optimization, scale-up, and manufacture of small molecule active pharmaceutical ingredients (APIs) in a remote setting, ensuring compliance and efficiency throughout the product lifecycle.

Key Responsibilities

• Develop and execute phase-appropriate drug substance development strategies from candidate nomination through commercial readiness
• Lead a team of scientists and process chemists to ensure technical excellence and operational efficiency in drug substance development activities
• Manage external manufacturing partnerships and contribute to regulatory submissions and compliance documentation

Required Qualifications

• PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline preferred
• 15+ years of experience in pharmaceutical or biotechnology drug substance development
• Demonstrated leadership experience in small molecule process chemistry and API development
• Proven success in advancing small molecule programs through late-stage clinical development and commercial readiness
• Extensive experience managing contract development manufacturing organizations (CDMOs) and external development partners