Teams at Bicara Therapeutics

Own and continuously improve risk-based GxP audit programs covering clinical sites, vendors, and internal processes. Lead audit planning, execution, reporting, response resolution, CAPA completion, inspection readiness, auditor management, compliance trending, metrics, and audit-record maintenance. Apply global GMP/GCP regulations, manage stakeholders and contract auditors, and refine quality processes, tools, and templates.

Leads biostatistical strategy and serves as lead statistician for oncology clinical programs. Designs and analyzes trials, contributes to protocols and statistical analysis plans, oversees analyses and reporting, manages CRO and vendor deliverables, supports regulatory submissions and scientific publications, and promotes statistical understanding across cross-functional teams.

Serve as FP&A business partner to Development functions (Clinical, CMC, Supply Chain, Regulatory). Lead budgeting, long-range planning, trial forecasting, cost-of-goods analysis, KPI development, financial consolidation in Adaptive Planning, and scenario modeling to support pipeline, launch, and lifecycle decisions.