Jobs at Otsuka America Pharmaceutical

The Associate Director will lead the transformation and implementation of a unified HCP engagement model in R&D, ensuring compliance, operational excellence, and the highest standards of service while managing a direct report and overseeing performance metrics.

The Senior Director, Biostatistics leads a biostatistics team in clinical development, overseeing statistical strategy, trial design, and regulatory submissions. Responsibilities include mentoring staff, ensuring operational excellence, and fostering collaboration across projects.

Leads U.S. market access proposal, pricing, contracting, and deal governance across payers, PBMs, GPOs, specialty pharmacies, and institutional customers. Oversees analytics, business cases, contract development, approvals, performance dashboards, lifecycle strategy, and process automation. Partners with Market Access Strategy, Finance, Legal, Commercial Analytics, IT, and account teams to optimize deal structures, gross-to-net impact, value-based agreements, and product strategies. Builds enterprise capabilities, improves analytical models, supports customer engagements, and develops a high-performing team.

Leads global supplier quality performance management for pharmaceutical and biopharmaceutical suppliers, CMOs, CDMOs, packaging vendors, and laboratories. Responsibilities include monitoring KPIs, maintaining dashboards, analyzing trends, presenting quality insights, coordinating risk-based supplier audits, managing quality agreements, and supporting deviations and CAPAs in TrackWise Digital. The role ensures supplier compliance with global GMP, GDP, GxP, and applicable regulatory requirements while partnering with Quality, Technical Operations, Supply Chain, and external suppliers.

Manages global supplier quality performance for pharmaceutical and biotechnology suppliers, including CMOs, CDMOs, laboratories, and packaging providers. Responsibilities include monitoring KPIs, developing dashboards and reports, supporting supplier audits and qualification, tracking CAPAs, maintaining Quality Agreements, assessing supplier risks, and managing supplier records in TrackWise Digital. The role collaborates with Quality, Technical Operations, Supply Chain, Regulatory Affairs, and external suppliers to maintain GMP, GDP, and regulatory compliance.

Leads global supplier quality management for pharmaceutical development and commercial operations. Responsibilities include supplier qualification, risk assessments, GMP audits, CAPA review, performance monitoring, regulatory inspection support, quality-system optimization, and continuous improvement. Partners with Procurement, Supply Chain, Manufacturing, Regulatory Affairs, and Quality teams while guiding auditors and colleagues. Requires significant pharmaceutical, biotechnology, or medical-device quality experience, including independent leadership of external supplier GMP audits and domestic and international travel up to 50%.

Lead and scale a national strategic accounts organization for rare neurology, recruiting and coaching ~10 account managers, owning sales strategy and execution, engaging top-tier accounts, navigating access/reimbursement and treatment logistics, and driving cross-functional alignment to support launches and patient access.

This role leads data and AI engineering strategies for R&D, oversees a team of engineers, and ensures compliance with regulatory standards while fostering innovation and collaboration across functions.

Lead development and governance of RBQM frameworks across clinical trials. Drive risk assessment, mitigation, centralized monitoring, analytics-driven oversight, vendor alignment, regulatory inspection readiness, process improvement, and financial and people management to ensure compliant, efficient trial execution.

The Associate Director in MSAT - Analytical Sciences will lead the analytical support for biologics manufacturing, overseeing method validation, compliance, and operational excellence during tech transfers.

Lead primary market research, competitive intelligence, and analytics for a rare neurology brand; design and own insight plans and budgets; support launch preparation; manage and coach a team; synthesize primary and secondary data to generate actionable insights and influence cross‑functional decisions to drive brand performance.

Lead market research, competitive intelligence, and analytics for a rare disease brand to support launch and lifecycle strategy. Develop and own insight plans, manage budget and team, synthesize primary/secondary data into actionable recommendations, and collaborate with cross-functional stakeholders to drive brand performance in the US.

The Director oversees U.S. marketing for Neuroscience, driving brand strategy, market assessments, and lifecycle management, collaborating across teams to ensure successful commercialization and strategic growth.

Lead development and execution of a marketing excellence strategy for the CNS business unit, defining future marketing competencies, building capability and learning programs, standardizing brand planning and marketing best practices, and partnering cross-functionally to drive talent development, omnichannel execution, and marketing analytics across the organization.

Lead development, qualification, validation, and lifecycle management of cell-based and ligand-binding bioassays to support biologics from early development through commercial stages. Provide SME input to CMC, Regulatory, Quality, and Process Development, oversee method transfer and outsourced testing, ensure GLP/GMP compliance and data integrity, author regulatory and technical documentation, and drive assay strategy for IND/BLA/MAA and post-approval changes.

Hands-on technical leader executing downstream biologics process development: design, optimize, scale-up and transfer purification processes (chromatography, filtration, UF/DF, viral clearance). Drive CDMO interactions, review and approve documentation, support regulatory filings and ensure cGMP and quality compliance.

Lead U.S. market access, payer marketing, pricing, and reimbursement strategies across inline and pipeline CNS products. Develop payer value propositions, access narratives, pricing and contracting recommendations, payer-facing resources, and evidence/value strategies. Influence cross-functional stakeholders, manage budgets and agency partners, monitor market/payer trends, and support launch, lifecycle management, and business development to optimize patient access and value realization.