Clinical Trial Lead

US-NJ-Princeton
Requisition ID
2017-9803

Overview

Our Mission: Otsuka-people creating new products for better health worldwide

 

Welcome to Otsuka
These are exciting times for all of us at Otsuka in the U.S. We not only have a rich portfolio of products making real differences in areas of unmet medical need, but we also have many investigational products at various stages of development. Our work in digital medicine promises to pioneer a new behavioral healthcare paradigm, and our commitment to patients persists in our transformative support programs.

 

Otsuka-People
Turning vision into reality requires passion, leadership, dedication, diversity of thought, collaboration, and perseverance. Otsuka-people have these qualities in abundance, and we support them by providing a dynamic work environment that encourages them to explore ideas, seize opportunities, and grow in meaningful ways. Our passionate leadership and unique culture, combined with access to continuing education, a unique workspace, and top-of-the-line 401(k) retirement savings plans with matching contributions, among other benefits, make Otsuka a truly different place to learn and grow.

 

www.otsuka-us.com

Responsibilities

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.

Qualifications

  • 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%) 

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