Teams at Otsuka America Pharmaceutical

Leads statistical programming for clinical trials, including development and validation of SDTM and ADaM datasets, tables, figures, and listings. Oversees regulatory submission deliverables, programming standards, quality reviews, vendor interactions, process improvements, automation, and adoption of AI-enabled programming tools. Collaborates cross-functionally, supervises contract workers, and ensures outputs meet regulatory, traceability, reproducibility, and quality requirements.

Leads the commercial strategy, sales, marketing, launch optimization, market development, financial performance, and organizational growth for a nephrology pharmaceutical brand. Oversees marketing, field sales, operations, thought leader engagement, cross-functional collaboration, P&L, business planning, patient access, and market expansion. Builds a high-performing commercial organization while ensuring compliance and alignment with medical, regulatory, legal, market access, finance, and patient services teams.

Leads global R&D Quality across clinical, pharmacovigilance, and regulatory operations. Oversees inspection readiness, clinical and vendor audits, regulatory authority engagement, data integrity, quality systems, CAPA effectiveness, risk mitigation, management reviews, policy development, and departmental budgets. Builds and develops international QA teams while ensuring GCP, cGMP, QSR, and applicable regulatory compliance across development through commercialization.