Director, CMC — Small Molecule Oncology

Pathos AI; New York (NY); On-site; USD 250,000 - 360,000; Full time

Job summary

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

You will partner with the Head of CMC and collaborate with Research, Clinical, Regulatory, and Quality teams in a fast-moving environment.”

Qualifications

• Deep expertise in end-to-end CMC strategy for oncology programs.
• Owns drug substance and drug product development from early to late stages.
• Ability to translate program goals into phase-appropriate plans and budgets.
• Collaborates with Research, Clinical, Regulatory and Quality teams.

Responsibilities

• Define and execute end-to-end CMC strategy for API and drug product.
• Lead cross-functional program teams with clear accountability.
• Oversee process development, formulation, and analytical method development.
• Manage external CDMOs/CMOs for tech transfer and scale-up.
• Ensure timely clinical supply and regulatory-ready documentation.

Job description

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

You will partner with the Head of CMC and collaborate with Research, Clinical, Regulatory, and Quality teams in a fast-moving environment.”