Clinical Trial Lead

Requisition ID


OPDC: Striving to disrupt the typical pharmaceutical development paradigm

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is where some of the best scientific minds in the world of pharma apply their innovative skills to investigating new drugs.


The Clinical Management team skillfully executes all phases of clinical trials for all portfolio assets across OPDC. We break from traditional clinical operations and utilize strategies at the intersection of technology and therapeutics, and have been transforming the clinical trial model in the process. We deliver high quality clinical trial data and submissions while defining the new wave of clinical trial execution.


Do you want to do extraordinary things and have an impact on the future of our business?


The Clinical Trial Lead manages the operational components for assigned domestic and global protocol(s) to ensure proper conduct and timely completion of project(s), including the contribution to the development and implementation of study strategy. This person serves as primary contact for external team members for protocol related issues. This person oversees the external team members in their conduct of the day-to-day operations of assigned protocol(s), including:

  • Development of ICFs, study plans, and other study-related documents
  • Study planning, execution, and risk mitigation
  • Site selection
  • Reviews study-related surveillance and reporting (enrollment,monitoring, regulatory documents, etc)
  • Conducts real-time review and analysis the study data and trends, with escalation to appropriate stakeholders. 

This person ensures that program activities are conducted following the protocol, ICH
GCP and all applicable global regulatory requirements. This person will drive and embrace various change initiatives including technology integration.


  • Bachelor’s degree required, minimum 2 years clinical trial management or relevant experience
  • Strong communication, organization, planning, analytical, problem solving, and people management skills.
  • Agile leader that has demonstrated the ability to drive and influence change
  • Travel (approximately 20%) 


Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at Learn more about Otsuka in the U.S. at

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