Jobs at Otsuka America Pharmaceutical

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 design, delivery, and governance of global Commercial and G&A learning programs aligned with regulatory (GxP/ICH/FDA/EMA) and business requirements. Drive learning strategy, stakeholder engagement, training content and delivery (instructor-led, virtual, e-learning), metrics, audit-ready documentation, and continuous improvement 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.

Manage and oversee clinical trial operations activities including TMF, site monitoring, vendor oversight, study startup, RBQM, KPIs, resource allocation, compliance, and budget management. Lead cross-functional collaboration, continuous improvement, escalation management, and direct line management where applicable to ensure timely, high-quality delivery of clinical studies.

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 is responsible for overseeing global labeling processes, ensuring compliance, collaborating with teams, and managing documentation for drug products.

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.

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 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.

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.

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.