Clinical Operations, Associate Director (14m JPY+)

Tokyo 23 Wards Permanent ¥10,000,000 - ¥14,000,000 Foreign Multinational
  • Contribute to an Expanding Global Pharmaceutical Business in Japan
  • Work with US HQ to Translate and Execute Clinical Trial Protocol in Japan

About Our Client

  • Global pharmaceutical company with a growing presence in the APAC market

Job Description

  • Lead strategic planning for clinical development programs in Japan
  • Develop clinical synopsis, protocols and amendments, investigator brochures, and clinical study reports with global clinical development
  • Lead clinical study team and provide appropriate monitoring for clinical studies including CRO oversight
  • Evaluate pharmacology, safety and efficacy data from ongoing and completed studies
  • Conduct literature reviews and prepare summaries to support clinical development programs
  • Be a resource for design and interpretation of clinical and preclinical programs to support existing and new development pipelines
  • Evaluate potential business development opportunities and conduct due diligence for assessing scientific, medical and development feasibility
  • Interact with key opinion leaders related to assigned compounds and therapeutic area
  • Contribute to JNDA, NDA, and MAA filings and prepare relevant sections of the regulatory documents

The Successful Applicant

  • University degree, preferably in medical or biological sciences or discipline associated with clinical research.
  • An advanced degree (MSc, PhD) in Science or Engineering, PMP certification, Masters of Business Administration (MBA) or equivalent is preferred.
  • Extensive experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization).
  • In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals (CMC, non-clinical, clinical, and regulatory).
  • Broad experience as a project manager leading cross-functional project teams in a matrixed, global environment, including those with complex technical, geographic, and/or regulatory elements.
  • Demonstrated experience in leading cross-functional teams and delivering projects to meet business objectives on time, within budget and with quality.
  • Participate in the learning and development of junior Project Management staff and provide mentoring and coaching.
  • Proficient in the use of Project Management processes and tools (e.g. Microsoft Project).

What's on Offer

  • Lead and manage clinical operations for Japan R&D
  • Work in an expanding global pharmaceutical business, contribute to start-up activities
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

What is your area of specialisation?
Healthcare / Pharmaceutical
Tokyo 23 Wards
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type
Foreign Multinational