Director, Small-Molecule CMC & AI-Driven Development

Pathos; New York (NY); Hybride; USD 210 000 - 250 000; Plein temps

Résumé du poste

Pathos is seeking a Director of CMC - Small Molecule Chemistry to lead the chemistry, manufacturing, and controls strategy for our oncology programs. You will own drug substance and product development from early clinical supply through late-stage development, ensuring quality, robust processes, and regulatory-ready documentation.

This foundational role partners with the Head of CMC and teams across Research, Clinical, Regulatory, and Quality in a fast-paced environment.

Qualifications

• Ph.D. in Synthetic Organic Chemistry, Medicinal Chemistry, or closely related field.
• 8-10+ years of pharma/biotech CMC experience.
• Experience in oncology drug development.
• Hands-on development across phase 1-3 and late-stage.
• Experience managing CDMOs/CMOs and tech transfer.

Responsabilités

• Define and execute end-to-end small-molecule CMC strategy for oncology programs (API and drug product).
• Lead CMC program and represent in cross-functional teams with Research, Clinical, Regulatory, and Quality.
• Develop phase-appropriate development plans, budgets, and risk mitigation strategies.
• Oversee drug substance/formulation and analytical development.

Connaissances

Oncology drug development

CMC strategy

Cross-functional leadership

Strategic thinking

Formation

PhD in Synthetic Organic or Medicinal Chemistry

MS/BS with commensurate experience

Outils

Regulatory submissions

Description du poste

Pathos is seeking a Director of CMC - Small Molecule Chemistry to lead the chemistry, manufacturing, and controls strategy for our oncology programs. You will own drug substance and product development from early clinical supply through late-stage development, ensuring quality, robust processes, and regulatory-ready documentation.

This foundational role partners with the Head of CMC and teams across Research, Clinical, Regulatory, and Quality in a fast-paced environment.