VP, Small Molecule Drug Development and Manufacturing

Role Summary

The VP of Small Molecule Drug Development and Manufacturing provides strategic direction, technical guidance, and long-range planning for small molecule drug development (API and DP), CDMO evaluation and selection, tech transfer, and GMP manufacturing from IND-enabling studies through NDA submission and approval and into commercial launch.

Responsibilities

• Establish and execute a risk-based small molecule drug development and manufacturing strategy (API and DP) to support commercialization of the company's small molecule pipeline assets.
• Lead small molecule drug development and manufacturing efforts from IND enabling to NDA submission and approval, and post-approval lifecycle management.
• Lead the evaluation and selection of CDMOs for small molecule drug development and GMP manufacturing.
• Oversee outsourced small molecule drug development and manufacturing activities including process/formulation development/optimization, tech transfer and scale-up, process characterization and process validation at CDMOs, ensuring quality, compliance, and timely execution and delivery.
• Build and lead a small molecule drug development and manufacturing team; hire, mentor, and develop team members aligned with company values and culture.
• Author, review, and approve the relevant CMC sections to enable global regulatory filings (INDs, NDAs, MAAs) and participate in regulatory authority interactions and inspections.
• Collaborate with CDMOs, proactively manage API and DP-related risks and implement mitigation strategies to ensure project success.

Qualifications

• Degree (BS/MS/PhD) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related fields.
• 18+ years hands-on experience in small molecule drug development from process/formulation development and optimization, process characterization to process validation, CDMO selection and oversight, tech transfer and GMP manufacturing.
• Proven experience leading small molecule drug development and manufacturing from IND enabling to NDA/MAA submission, approval and commercial launch.
• Demonstrated success managing fully outsourced small molecule drug process/formulation development, tech transfer and scale-up, and GMP manufacturing.
• Working experience with FDA and EMA. Strong knowledge of cGMP, ICH guidelines, and global regulatory expectations.