Teams at Eisai US

Lead translational strategies across neurology programs, design multimodal biomarker approaches, integrate preclinical and clinical data, support trial design and regulatory submissions, collaborate cross-functionally, and present findings externally. Focus on non-Alzheimer's neurodegenerative diseases and deliver data-driven decisions from discovery through early clinical development.

Lead development, review, approval, and maintenance of Company Core Data Sheets (CCDS), Country Product Information (CPI) and related components. Coordinate cross-functional teams, provide regulatory labeling strategy and tactical guidance, manage direct reports, ensure SPL compliance for US submissions, maintain labeling history, and support global labeling intelligence and special GRN/GL initiatives.

Manage clinical data activities from study start-up through completion, develop eCRFs/DMPs/validation and data transfer specs, oversee CROs and internal teams, ensure GCP/SOP/regulatory compliance, represent Data Management on study teams, mentor staff, and deliver quality data.