Summary:

The Global Integrated Evidence Operations, Associate Director role primarily focuses on leading and logistical management of integrated communication & evidence planning (ICEP) process steps, which includes managing end-to-end project plans and operational activities for developing/maintaining ICEPs in our digital planning solution. The Global Integrated Evidence Operations, Associate Director works closely with Global Integrated Evidence Strategy lead and collaborates with cross-functional teams to manage the creation and refresh cycles of ICEPs for prioritized assets and programs, ensuring comprehensive evidence packages are available to support regulatory, launch, and post-launch strategies. In addition, the role will be critical in facilitating evidence planning and generation governance at both the leadership and team level to ensure plans are aligned with the asset vision and individual studies align with strategic objectives of ICEPs.

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. 

Responsibilities:

• Support the creation and management of individual ICEPs with a focus on operational efficiency by building out and maintaining digital planning platform/repository:
  • Gathering and organizing materials
  • Conducting meetings and workshops with cross-functional teams
  • Developing pre-reads and meeting content
  • Recording notes and integrating feedback into final outputs

• Post outputs to the digital ICEP planning platform/repository and monitor progress of approved tactics.
• Track and report updates to the Global Integrated Evidence Strategy lead for timely reviews and refresh cycles.
• Identify connections between new or existing studies and ICEPs using digital planning platform/repository.
• Ensure operational excellence through the continued development and implementation of standardized processes, tools, and governance for ICEPs.
• Contribute to the development of operational KPIs and dashboards to monitor performance and drive continuous improvement for ICEPs.
• Facilitate evidence planning governance to ensure alignment with asset vision and strategic objectives.
• Facilitate evidence generation governance to oversee the execution of evidence generation activities.
• Contribute strategic thinking and thought partnership in planning and discussions for both ICEP and governance.
• Manage logistics for ICEP and governance processes, including scheduling meetings, preparing content, and synthesizing feedback.
• Recommend process improvements and efficiencies to Global Integrated Evidence team.
• Develop and maintain relationships with colleagues involved in the ICEP and governance processes.

Requirements:

• Bachelor's degree in life sciences.
• At least 5 years of experience in pharmaceutical and/or evidence generation and/or digital health in life sciences / technology sector.
• Competence in drug development lifecycle and scientific understanding of assets.
• Demonstrated solid understanding of evidence requirements in US and globally, key concepts and principles related to Ph1-4 clinical studies and non-interventional studies including an understanding of strengths and limitations of a methodological approaches and clinical trial designs.
• Possess an enterprise mindset and experience establishing strong collaborative internal relationships in a matrixed organization with global and local colleagues.
• Ability to gain senior leadership alignment on functional area initiatives and programs.
• Excellence in strategic thinking and problem solving.
• Demonstrated skills working in complex corporate environments and exercising influence without authority.
• Ability to create an environment with high energy, enthusiasm, and motivation.
• Ability to thrive under pressure, meet deadlines, and lead parallel projects.
• Strong scientific writing skills and interpersonal written/verbal communication skills.
• Capability to synthesize large amounts of data into meaningful content.
• Excellent project, time management, and organizational skills.

Preferred:

• Formal training or certification in project management methodologies (PMP, Six Sigma, Agile).
• Experience in developing IEPs or managing complex processes across cross-functional stakeholders.
• Experience in leading or working closely with leadership governance.
• Successful execution and management of multiple projects supporting life sciences research.
• Technical experience in drug development/commercialization.
• Knowledge of drug development lifecycle functions such as Discovery, Clinical Trials, and Regulatory.
• Experience with digital technology to support management of planning and research.