Position Summary: -The Director GVE Operations oversee and coordinates projects within the department to ensure alignment with organizational goals. This role is crucial for enhancing the efficiency and effectiveness of GVE operations to support the timely, efficient, and compliant delivery of real-world evidence (RWE), health economics and outcomes research (HEOR), and other integrated data generation initiatives.This position reports to the Senior Director, Global Integrated Evidence & Innovation Operations and can be based in Princeton, New Jersey. Otsuka maintains a hybrid work policy -and remote options will be considered for US candidates. -Key Responsibilities: -

• Streamline and refine GVE processes to ensure quality, compliance, and timely delivery of value evidence studies.
• Optimize, develop and implement operational frameworks, SOPs, processes, checklists and guidance documents to support study execution. -
• Monitor study performance and proactively address risks and issues. -
• Ensures study budgets are realistically set and attained and effectively communicates status of projects.
• Coordinating the management of GVE department projects including setting timelines and ensuring that milestones are met.
• Support strategy leads by managing the study operational execution of studies including protocol development, vendor selection, contracting, timelines, and budget oversight.
• Manage budget for GVE department and ensure projects are completed within financial constraints.
• Develop and maintain relationships with key functions involved in GVE (e.g., Medical Affairs, Market Access, Data and Analytics) and promote interaction between different departments to leverage expertise and ensure cohesive project execution. -
• Contribute to the development of key performance indicators (KPIs) to monitor the progress and success of projects for the GVE department. Regularly review these metrics to identify areas for improvement.
• Develop and deliver training programs for the department to build a culture of continuous improvement.
• Stay current with global regulatory and compliance requirements related to evidence generation and data use. -Qualifications: -
  • Bachelor's degree in life sciences ---
  • -5+ years of experience in the pharmaceutical, biotech, or healthcare industry, with a strong background in HEOR, RWE, or clinical operations.
  • Proven track record of leading global evidence generation initiatives and managing cross-functional teams.
  • Deep understanding of global HTA requirements, payer evidence needs, and regulatory frameworks.
  • Strong project management, vendor oversight, and budget management skills.
  • Excellent communication, leadership, and stakeholder engagement capabilities.Preferred Qualifications: -
    • Advanced degree (PhD, PharmD, MD, or Master's in Public Health, Epidemiology, Health Economics, or related field).
    • Experience with digital health data, real-world data platforms, and advanced analytics. -
    • Familiarity with HTA and payer evidence requirements. -
    • Experience working in a matrixed, global organization.