Overview of Role:

The Director, Clinical Operations Japan, is accountable for providing leadership and operational expertise into execution of one or more phase 1-3 clinical trials conducted in Japan. The role will be part of the Global Clinical Operations (GCO) group reporting into USA VP, Head of Clinical Operations. This position is expected to:

• Collaborate with Contract Research Organization (CROs) and identify, champion, and implement key improvements in the outsourced operating model for optimization, performance, and site engagement
• Strategize local needs and help build resource needs to support the clinical trial delivery strategy in an effective, efficient, and compliant manner
• Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders
• Lead and inform the direction & strategy for a potential insourced clinical trial model for Japan in alignment with global strategy

Role and Responsibilities:

• Accountable to lead, manage and drive operational excellence in Japan. This will be accomplished through CRO delivery and considerations of future internalization of GCO’s operating model where appropriate.
• Responsible for operational deliverables in Japan in accordance with time, cost, and quality commitments
• Function as a key point of escalation for issues and problem resolution impacting new and ongoing studies to ensure business critical milestones are achieved for Japan
• In accordance with the global strategy and pace, support the creation and direct on a Japan regional strategy including resource requirements and capabilities needed
• Build strong relationships with Summit Study Leads and Study Cross-Functional Teams. They will leverage this information to help guide in operational direction of disease area expertise and country specific expertise specific to Japan needs.
• Feasibility:
  • Understands and highlights country specific strength and opportunities in the creation of the strategy for selection of countries/sites for Japan
  • Ensures timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans to enable effective and efficient delivery to plan
• In partnership with the global study team, maintains Japan risks, proactively communicates progress, issues or changes that may impact timelines and costs. Identifies trends & patterns across study and program level and supports mitigation and prevention of Japan specific systemic issues and risks.
• Accountable for the study level quality, and compliance with GCP, local laws and regulations and guide the team with local HA inspection readiness
• Line management of regional team in line with business needs. This may include but not limited to GCO roles in the following areas - study management, site engagement, and/or other local staff working from the Japan region.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• BA/BS required; in a scientific/medical field preferred; Advanced degree preferred
• A minimum of 10+ years industry or related experience
• Extensive early/late-stage drug development oncology experience ideally including time in role such as a Local or Global Study Leader
• Knowledge and experience of drug development in Japan region
• Proven line and performance management experience; functional management experience, managing resourcing and budget planning and oversight
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment
• Proven organization design and change management experience
• Excellent written and verbal communication skills
• Proven ability to develop successful collaborations with internal and external partners