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TakedaPosted 1 month ago

Medical Director, Global Clinical Science, Immunodeficiency (f/m/d), Hybrid

$237,200–$372,790 year

HybridBoston, Massachusetts, United States

Full TimeSenior LevelEnterprise

Job Summary

Lead global clinical development for Immunodeficiency pipeline compounds across US, EU, and Japan, driving strategy and delivering Clinical Development Plans and Protocols. Monitor and interpret data from ongoing internal and external studies to assess medical and scientific implications, making high-impact decisions that influence regional and global development. Prepare and approve synopses and protocols while serving as advisor to Associate Medical Directors and clinical scientists. Manage trial medical monitoring activities, assess protocol conduct and subject safety issues, and direct interactions with regulatory authorities and key opinion leaders. Evaluate business development opportunities, conduct due diligence for alliances and in-licensing, and serve as clinical contact point for partner negotiations. Report to the Head of Primary Immunodeficiency Clinical Science with approximately 10-20% travel.

Required Qualifications

  • M.D. or internationally recognized equivalent degree
  • 3-5 years of strong clinical research/drug development experience within the pharmaceutical industry
  • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions
  • NDA/MAA Submission experience
  • Knowledge/experience in Immunology, or a related specialty, disease mechanisms and plasma derived/related therapies
  • Regional/global Regulatory requirements
  • Travel Requirement is approximately 10 - 20%

Desired Qualifications

  • Additional advanced degree, e.g. Ph.D.
  • Clinical Immunologist or Allergy / Immunology Specialist or Internal Medicine Specialist
  • Management experience

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