Clinical Development Lead

Tokyo 23 Wards Permanent Foreign Multinational
  • Lead Clinical Development Programs for Cardiovascular and Metabolic Diseases
  • Drive R&D Strategic Planning and Execution across the Company

About Our Client

  • Leading pharmaceutical company globally.
  • Developing drugs across the following therapeutic areas: Oncology, Infectious Diseases and Vaccines, Immunology, Cardiovascular and Metabolism.

Job Description

  • Responsible for planning/execution/reporting of clinical studies and health authority interactions on clinical matters.
  • Maintain high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by Japan clinical science team
  • Responsible for talent development of other Japan Clinical Development members
  • Leads primary publication of clinical study data
  • Responsibilities for health authority interaction
  • Develops clinical section of Briefing Book for PMDA consultation(s)
  • Develops clinical section of Common Technical Document (CTD)
  • Generates responses to clinical inquiries from health authorities
  • Supports PMDA inspection on clinical matters.
  • Supports development of Risk Management Plan and J-package insert
  • Accountability for clinical data
  • Accountable for interpretation of all clinical data in assigned indication(s) and compound(s)
  • Presents scientific and clinical information, and leads clinical discussions with internal/external stakeholders including health authorities

The Successful Applicant

  • Medical or Life Sciences degree or equivalent qualification
  • Experience in managing or leading global or multi-country project
  • Experience in project management and/or team leadership, functional line management in one or more of the Pharmaceutical functions.
  • Ability to respond flexibly to changing project priorities and work assignments.

What's on Offer

  • Excellent career development opportunities
  • Competitive salary package and benefits
  • Strong pipeline including: Oncology, Infectious Diseases and Vaccines, Immunology, Cardiovascular and Metabolism.
Contact
Ed Marsden
Quote job ref
4209600
Phone number
+813 6832 8981

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
4209600
Company Type