Jobs at Otsuka America Pharmaceutical

The Associate Director, Biostatistics will provide statistical expertise in drug development, oversee statistical tasks, and collaborate with various teams to support clinical trials.

The Associate Director of CDMO Strategic Sourcing will develop and execute sourcing strategies, manage supplier relationships, lead contract negotiations, and ensure compliance with regulatory standards in drug manufacturing.

The Neuroscience Specialist engages healthcare providers, coordinates with cross-functional teams, and enhances customer experiences while delivering knowledge on pharmaceutical products.

The Neuroscience Specialist engages healthcare providers, facilitating discussions and enhancing customer engagement through various outreach strategies, while reporting to the Area Business Lead.

Pharmaceutical commercial role engaging healthcare providers on approved neuroscience products via in-person, virtual, and digital channels. Responsibilities include proactive outreach, speaker programs, local provider group facilitation, elevating market insights to leadership, collaborating cross-functionally, and supporting territory business planning to drive patient access and product adoption.

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.

Lead operational oversight of the company LMS including GxP workflows, audience and curriculum management, reporting, tier-one troubleshooting, vendor coordination, and LMS training. Partner with business and technology stakeholders to implement improvements, ensure compliance, and run scheduled and custom reports to support training initiatives and decision-making.

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.

Lead strategic sourcing for R&D CRO-related categories, developing supplier partnerships, driving 10-15% annual savings, ensuring regulatory and quality compliance, negotiating master agreements, measuring KPIs, and managing a team of sourcing managers to support timely, high-quality clinical trials.

The Associate Director supports pharmacometrics activities including study design, data analysis, and reporting, serving as a lead in drug development strategies.

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

The Neuroscience Specialist engages healthcare providers, conducts outreach, facilitates discussions, and elevates insights to inform strategic decisions while maintaining compliance and enhancing patient care.

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.