Clinical Development Lead

1 week ago


Markham, Ontario, Canada Astellas Full time
About the Role

Astellas is seeking a highly skilled Medical Lead to join our Clinical Development team. As a key member of our team, you will be responsible for providing medical and strategic leadership in the planning, design, and conduct of clinical trials.

Key Responsibilities
  • Design and Execution of Clinical Development Plans: Develop and implement clinical development plans for investigational products, ensuring alignment with regulatory requirements and business objectives.
  • Global Development Team Leadership: Lead global development teams to design, implement, and conduct multi-phase development studies to support regulatory submissions and post-approval filings.
  • Medical Program Management: Manage medical programs, including post-marketing requirements, to ensure successful execution and delivery of clinical development plans.
  • Competitor Intelligence: Stay up-to-date on competitor products and their impact on internal medical and commercial strategies.
  • Resource Planning and Budgeting: Plan and manage resources, including employees and contractors, to achieve clinical development objectives in a timely and resource-efficient manner.
  • Clinical Development Budgeting: Collaborate with Clinical Operations to develop and recommend clinical development budgets.
  • Team Motivation and Communication: Motivate global development teams to achieve common goals, including submitting approvable regulatory filings.
  • Clinical Progress and Safety Monitoring: Monitor clinical progress and emerging safety profiles, ensuring timely communication to stakeholders.
  • Protocol Development and Review: Develop, review, and communicate protocol synopses, major protocol amendments, and clinical documents.
  • Medical Expertise and Communication: Provide medical expertise and communicate with senior management, external audiences, and clinical expert panels on various medical aspects of drug development.
  • Health Economics and Outcomes Research: Incorporate Health Economics Outcomes Research requirements into protocol design.
  • Medical Monitoring and Safety: Oversee medical monitoring strategy and escalate potential safety signals and concerns.
  • People Management: Serve as a people manager, monitoring employee performance, offering feedback, and encouraging professional growth.


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