Teams at Eisai US

Oversee outsourced analytical testing, product release, stability programs, assay troubleshooting, validation, technology transfers, and protocol/report reviews for biologics from pre-IND through Phase 3. Manage external laboratories, CMOs, suppliers, budgets, timelines, and cross-functional communications while ensuring compliance with FDA, EMEA, ICH, JP, and cGMP requirements. Support stability, shelf-life, manufacturing, and regulatory development decisions for biologic therapies.

Develops and implements biopharmaceutical public policy strategy focused on Medicare Part D, CMS reimbursement, drug pricing, and patient access. Analyzes legislative and regulatory developments, advises executives, represents Eisai with policymakers and industry groups, and integrates policy strategies across disease, pipeline, and product teams.

Leads biostatistics activities across clinical development, including trial design, statistical analysis, regulatory submissions, CRO and vendor oversight, dataset and TLG validation, and manuscript development. Directs complex global registration studies, supports regulatory interactions, develops statistical processes and SOPs, and manages biostatistics teams, budgets, talent development, and performance. Collaborates with clinical, data management, project management, and external partners to advance efficient study designs and support approval strategies.