Jobs at Otsuka America Pharmaceutical

Field-based pharmaceutical sales role engaging healthcare providers via in-person, virtual, and digital tools to communicate on-label product information, facilitate speaker programs, organize local provider groups, elevate market insights to leadership, and collaborate cross-functionally to inform territory strategy and improve patient care.

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.

Lead US marketing and Thought Leader Liaison for a rare/ultra-rare neurology portfolio. Own end-to-end pre-launch and launch strategy, brand planning, financial targets, and cross-functional alignment. Build patient-centric teams, leverage field insights, identify patients, engage KOLs and advocacy groups, and adapt strategies in ambiguous, high-urgency environments. Travel required to support launch activities.

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.

Lead global supplier quality strategy and performance for critical external suppliers (CMOs/CDMOs). Oversee supplier qualification, audits, KPIs, scorecards, TrackWise Digital system ownership, quality agreements, risk mitigation, and executive reporting. Partner with Procurement, Supply Chain, Regulatory, and Technical Operations to drive data-driven improvements and ensure GMP/GDP compliance.

Lead design and implementation of process improvement initiatives for global clinical operations. Develop SOPs, process maps, KPIs, and training materials. Drive adoption of CoE standards, partner with cross-functional teams and external vendors, support change management, and ensure compliance with GCP/ICH and QMS requirements to improve trial efficiency, quality, and scalability.

Lead design and execution of process improvement initiatives across global clinical operations. Evaluate workflows, create SOPs and training, define KPIs, analyze performance, drive change management, partner with cross-functional teams and external vendors, ensure GCP/ICH compliance, support QMS CAPA, and mentor stakeholders to improve efficiency and scalability.

Lead design and implementation of process improvement initiatives across global clinical operations. Identify inefficiencies, develop SOPs and training, define and monitor KPIs, analyze performance data, drive change management and stakeholder engagement, partner with internal teams and external vendors, ensure GCP/ICH compliance, and support QMS/CAPA efforts to enhance operational efficiency and quality.

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.

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 will lead U.S. commercialization efforts for neuroscience assets, focusing on market assessment, competitive analysis, brand strategy, and portfolio planning to ensure successful product launches and investments.

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 QC operations for small-molecule GMP manufacturing including DS and DP release, analytical characterization, method transfer/validation, data integrity, OOS/OOT/CAPA oversight, inspection readiness (FDA/EMA), and support for regulatory filings (IND/NDA/ANDA). Manage QC laboratory teams, external labs/CROs, and continuous improvement initiatives to ensure compliant, robust product release and lifecycle management.

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.

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 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.