Jobs at Eisai US

Lead and manage statistical programming for clinical studies: develop and review SAS code, create SDTM/ADaM datasets and TLGs, implement Statistical Analysis Plans, collaborate with biostatistics/data management/clinical teams, oversee vendors, improve team processes/tools, and mentor junior programmers.

The Manager, Product Complaints oversees the complaint handling process for medical devices, ensuring compliance, data quality, and continual improvement in complaint resolution. Responsibilities include triage, investigation oversight, trend analyses, and maintaining quality systems.

Lead end-to-end network infrastructure operations across the Americas, overseeing SD‑WAN, LAN/WAN, wireless, cloud connectivity, Zscaler, firewalls, monitoring, vendor management, DR, security compliance, and a regional team to ensure high availability, performance, and alignment with Zero Trust and global standards.

The Sr. Manager HRIS - Workday role involves leading the configuration, optimization, and support of the Workday HCM platform, ensuring system integrity and collaboration across teams.

Lead design, engineering, and 24x7 operations of on-premises and cloud hosting (AWS/Azure) across the Americas. Own architecture standards, FinOps, cost optimization, migrations, DR, and compliance (GxP/FDA). Manage teams (60+), budgets, vendors, and enable the Global Capability Center to deliver cloud and infrastructure services.

Support QA operations for external manufacturing by performing batch record review, document archival in Veeva Vault, managing quality documentation, supporting deviations/investigations, assisting release activities, participating in audits, and contributing to continuous improvement to ensure cGMP and regulatory compliance.

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.

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 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.

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.

The Associate Director manages federal contracts, pricing strategies, compliance, and supports various governmental relations while leading cross-functional coordination and auditing processes.

Lead translational and biomarker strategy for neurology programs, bridging preclinical and clinical teams. Implement multi-modal biomarkers (biofluid, imaging, digital), analyze biomarker and clinical data, support assay implementation with CROs/academic partners, contribute to study design, regulatory documents, and scientific communications to inform program decisions.

Provide field-based access and reimbursement expertise for oncology and neurology products; support HCPs with payer education, escalate complex cases, train and mentor ARMs, liaise with internal stakeholders, ensure HIPAA/compliance, and travel to accounts and conferences to improve patient access to Eisai therapies.

The role involves leading IT project portfolios in Discovery R&D, managing resources, ensuring project delivery aligns with business needs, and overseeing project management practices.

Lead enterprise diagnostics and design integrated OD and learning solutions to drive culture, leadership capability, and organizational effectiveness. Manage large-scale transformation, program governance, stakeholder alignment, and measurement of learning impact using data, behavioral science, and AI-enabled tools. Partner with senior leaders and HR to build talent pipelines and scale leadership development.