Evidence Delivery Lead - 製薬会社

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

  • 世界100カ国以上で事業を展開トップクラスの企業

[Responsibilities]
Japan EOR Evidence Delivery Leader(EDL) is a project leadership role in delivering company sponsored scientific studies and medical evidence generation to support our business and value claims, in line with strategy, governance processes and standard operation procedures.

Business Planning & Control

  • EDL supports Therapeutic Area Medical Affairs (TAMA) Team in organizing the cross functional strategic evidence planning workshops for quality evidence plans
  • EDL supports Business Planning Process as EOR window person for each TA team so that the Evidence Generation costs are forecasted as per the agreed evidence plans
  • EDL contribute to ensure that Evidence plans/study concepts are scientifically and methodologically feasible to address research questions, feasible to time, cost, quality and capacity
  • EDL works with EDOS in planning and controlling to track and manage the progress of Evidence Generation programs as per the agreed business plans (RBU2/LRP/PB)

Company Sponsored Studies (Company SS) Delivery

  • EDL ensures the operational/methodological feasibility of the study concepts/plans to initiate
  • EDL is responsible to select the best external service providers (ESPs) as per the project requirements and manage the performance throughout the study
  • EDL leads delivery of all components of a scientific study to time, quality, budget, project standards, company quality standards, and scientific requirements during the course of the study from SDC development through database lock, analysis, reporting and study closeout activities
  • EDL is the cross-functional study team leader ensuring that studies are delivered by leverage company to address research questions
  • EDL contributes to uplift RWE capabilities of individuals involved in the Evidence Generation projects

[Requirements]

  • > 3years Clinical Study Leader experience
  • Leading protocol development, study site selection, data management, analysis, result-interpretation and reporting
  • Managing CROs for clinical studies
  • Master degree in a scientific discipline
  • Clinical Study Delivery
  • External Service Provider (i.e. CROs) Management
  • Leadership & Communication
  • Project Management
  • Practical English communication skill /TOEIC 800
  • Cross-functional Stakeholder management skill

[Preferred Knowledge, Skills and Abilities]

  • Researches using statistics and epidemiology
  • Working both in R&D and Medical (>3 years each)
  • Line management experience
  • Clinical Project Leader experience
  • Working experience in global organization / teams
  • PhD in a scientific discipline or MD or MPH
  • Study Design, Statistics and Epidemiology
  • Medical writing & Scientific Publication
  • Demonstrated English communication skills in Global Team or outside Japan

[Employment Type]
Full time

[Salary]
10M-12M yen
※Experiences and skills will be considered

[Location]
Tokyo


Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.