Jobs at Eisai US

Lead end-to-end external collaborations and alliance management, conduct search and evaluation of external opportunities, build scientific landscapes and KOL relationships, and integrate external innovation into internal program and portfolio strategy across neuroscience and other therapeutic areas.

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.

Leads quantitative systems pharmacology strategy and develops mechanistic mathematical models supporting drug discovery, clinical development, dose selection, efficacy and safety assessment, and translational decisions. Applies computational, statistical, and biological expertise across neurology, oncology, and other therapeutic areas; guides QSP platform development, advances model-informed drug development, collaborates across teams, presents scientific findings, and manages modeling deliverables.

Leads market access and account management training strategy for pharmaceutical commercial teams across neurology and oncology. Develops e-learning, workshops, assessments, classroom and experiential training; facilitates train-the-trainer programs; ensures regulatory review; manages budgets, vendors, stakeholders, direct reports, mentoring and team development. Requires pharmaceutical industry expertise, market access and reimbursement knowledge, account management experience, therapeutic-area familiarity, presentation skills, and virtual training design experience.

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.

Lead global regulatory labeling strategy and operations for neurology and oncology products. Oversee development and maintenance of CCDS, USPI, EU SmPC and country labels, manage labeling teams, EDMS repositories and workflows, ensure regulatory compliance and consistency, and liaise with partners and stakeholders.