Teams at Kailera Therapeutics, Inc.

Directs clinical data management across early- and late-phase trials, leading CRO oversight, vendor performance, data quality, risk mitigation, TMF documentation, inspection readiness, and cross-functional study collaboration. Develops data strategies, monitors program progress, ensures regulatory and SOP compliance, and supports audits and health authority filings.

Directs FP&A for Technical Operations, partnering with Drug Product, Drug Supply, and Global Supply Chain leadership. Owns budgeting, forecasting, long-range planning, COGS, capital expenditures, manufacturing costs, CDMO/CMO spend, and variance analysis. Builds financial models for scale-up, capacity planning, and make-versus-buy decisions; leads cross-functional initiatives, reporting improvements, and executive and board-level financial communications.

Lead global clinical data management strategy across all clinical development phases. Oversee data quality, eCRF builds, edit checks, integrations, reconciliations, data cleaning, database locks, submission readiness, regulatory compliance, CRO oversight, and inspection readiness. Build and develop a high-performing data management organization, establish governance and quality metrics, manage resources, and represent Data Management in cross-functional initiatives.