Medical Lead for Clinical Development

5 days ago


Markham, Ontario, Canada Astellas Full time

Astellas Pharma Inc. is a pharmaceutical company that conducts business in over 70 countries worldwide. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.

The Medical Lead will provide medical and strategic leadership in the planning, design, and conduct of clinical trials to enable successful development, registration, and access of an asset to patients.

Key Responsibilities:

  • Design and finalize clinical development plans for investigational products, soliciting input from colleagues in Regulatory Affairs, Commercial, and Medical Affairs.
  • Lead global development teams to design, implement, and conduct multi-phase development studies to support regulatory submissions.
  • Oversee medical monitoring strategies and escalate potential safety signals to the Medical Head.
  • Develop and recommend clinical development budgets in collaboration with Clinical Operations.
  • Presents medical aspects of drug development to senior management and external audiences.

Requirements:

  • Public knowledge of competitor products and their impact on internal medical and commercial strategy.
  • Negotiate milestones and ensure clinical development objectives are met.
  • Plan resources required for clinical development, including employees and contractors.


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