Associate Director - Clinical Operations

    Tokyo 23 Wards Permanent ¥11,000,000 - ¥13,000,000 Foreign Multinational
  • Biopharmaceutical company with focus on innovative rare disease pipeline
  • Opportunity to make a significant Impact on a small-mid size company

About Our Client

  • US headquartered pharmaceutical company with innovative development pipeline for rare immunological and neurological diseases

Job Description

    • Full responsibilities for studies led by the Japan Study Team. * Responsibilities in the global study is complied with Affiliate Involvement Model (AIM), Job aid and direction given by Global Clinical Trial Manager (CTM).
    • Responsibilities involve a combination of execution and oversight-dependent on the sourcing model - to ensure deliverables and may include, but are not limited to, the following:
    • Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget
    • Takes ownership and accountability for the development/management/reconciliation of overall study budget(s)
    • Development/management of vendor scope of work (SOW) per contract, quality, and budget
    • Review/approval of vendor invoices and management of accruals and SOW changes
    • Review/approval of site invoices and management of site budget
    • Drive study execution
    • Oversight of clinical monitoring quality and adherence to established processes and plans
    • Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions
    • Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
    • Maintenance/updating of data as appropriate in project management tools including CTMS
    • Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation

The Successful Applicant

  • Clinical trial project management skills
  • Financial budgeting and forecasting skills
  • Leadership / influence management skills
  • In depth knowledge of ICH/GCP, JGCP, regulatory guidelines/directives, and drug development and clinical research processes
  • Ability to effectively lead a cross-functional team in a matrix environmen
  • Time management skills - ability to effectively multi-task and prioritize
  • Proven problem solving and decision making skills
  • Demonstrated success in using oral and written communication skills to influence, inform, or guide others
  • Disease / therapeutic knowledge
  • Solid computer skills - requirement of MS applications including (but not limited to),Word, Excel
  • Study Tools including electronic system skills - CTMS / EDC
  • Creates realistic plans that clearly define goals, milestones, responsibilities and results
  • Maintains focus on strategic objectives while accomplishing operational goals
  • Places a priority on getting results with an emphasis on high quality outcomes
  • Holds self and others accountable for accomplishing goals
  • Makes timely, data-driven decisions
  • Develops and maintains effective working relationships with people across cultures
  • Encourages collaboration across teams, functions, and geographies
  • Ensures that conflict is handled constructively so that performance is not impacted
  • Displays a willingness to challenge the status quo and take risks
  • Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute
  • Maintains optimism and composure in times of change, uncertainty, or stress

What's on Offer

  • Work across rich development pipeline
  • Highly competitive remuneration package
  • Global career development opportunities
  • Flexible working arrangements (WFH options available)
  • Opportunity to make a significant impact on a small-mid size company
  • Contribute to development of innovative new drugs in areas of unmet medical needs
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

Healthcare / Pharmaceutical
Tokyo 23 Wards
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type
Foreign Multinational