Teams at Beeline Medicines

Lead end-to-end biologics drug product CMC development including formulation, fill-finish process development, CDMO selection/oversight, regulatory submissions (IND/BLA), stability and release strategy, clinical supply planning, and cross-functional alignment to enable clinical and commercial readiness.

Lead analytical method development, qualification, and validation for small-molecule drug substance and product. Own analytical control strategy, stability programs, forced degradation, method transfers, and regulatory analytical sections (IND/IMPD/NDA). Manage technical oversight of contract labs and CDMOs, ensure GMP and data integrity, support manufacturing analytics, and drive specifications, release testing, and cross-functional alignment as the primary analytical lead for assigned programs.

Provide strategic statistical leadership across Phase I-III clinical programs: design trials, author SAPs, oversee randomization and analysis, ensure CDISC-compliant delivery (SDTM/ADaM), lead regulatory statistical sections and interactions (IND/NDA/BLA/MAA), manage CRO statistical partners, build Biometrics function, and serve as a cross-functional quantitative advisor shaping program and regulatory strategy.