Jobs at Otsuka America Pharmaceutical

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 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.

Lead analytical strategy and technical oversight for third-party labs including method development/validation, stability testing, and investigational testing for small molecules and related modalities. Provide regulatory CMC support, structure elucidation using MS and other spectroscopic techniques, manage stability studies, author technical/regulatory documents, mentor team members, and collaborate cross-functionally to mitigate risks and align projects with timelines and quality/regulatory requirements.

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.

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.

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.

Individual contributor responsible for managing design history files and technical dossiers for combination products. Lead risk assessments, human factors/usability studies, specifications, design control documents, protocols, and technical reports. Coordinate cross-functional and external resources, develop project plans, and present status to teams and management. Ensure device verification, regulatory compliance, and transfer to CMOs. Frequent travel up to 15-20%.

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.

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.

Senior leader responsible for analytical development and QC strategies for small molecule drug substance and product across development and commercial lifecycle. Oversees method development/validation/transfer, QC operations (internal and external), regulatory submissions and inspections, CDMO/CRO oversight, and builds high-performing analytical teams to ensure cGMP compliance and data integrity.

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.