Jobs at Otsuka America Pharmaceutical

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.

Lead CMC data integration, analysis, visualization, and interpretation to support biologics development from IND through BLA and commercialization. Partner across Analytical Development, Process Development, MSAT, Quality, and Regulatory to generate regulatory-ready narratives, comparability assessments, control strategies, and data-driven CMC decisions. Ensure data quality, traceability, and regulatory fitness for internal governance and global filings.

Manage and optimize training operations for the Training Center of Excellence: coordinate governance and CoP meetings, lead LMS and learning projects, compile learning metrics and dashboards, maintain SharePoint communications, and support audits and inspections to ensure compliance and continuous improvement.

The Director of Statistics leads statistical initiatives in phase 3b/4 and RWE studies, provides expertise in HTA and regulatory compliance, and collaborates with cross-functional teams. Responsibilities include statistical analysis plans, Bayesian methodologies, and mentoring junior staff.

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.

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.

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 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 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.

Manage end-to-end relationships with assigned clinical vendors, oversee governance, CTMS maintenance, onboarding, metrics and scorecards, resolve escalations, support vendor qualification/audits, develop portfolio templates/handbooks, and coordinate internal stakeholder communications to ensure contractual and performance compliance.

Manage and oversee clinical trial operations activities including document management, site monitoring, vendor oversight, study startup, and RBQM. Establish and monitor KPIs, coordinate resources, manage risks, and ensure regulatory compliance and inspection readiness. Lead cross-functional collaboration, escalate project issues, drive process improvements, and provide operational oversight of external service providers. Contribute to budget management, vendor selection, and financial oversight for assigned trials.

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.

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.

Manage and oversee clinical trial operations including TMF, site monitoring, vendor oversight, study startup, KPIs, compliance, and resource allocation. Drive continuous improvement, cross-functional collaboration, escalation management, budget input, and oversight of external service providers to ensure trials meet timelines, quality, and regulatory standards.

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.

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.