Medical Lead, Clinical Development Strategist

2 days ago

Markham, Ontario, Canada Astellas Full time

About Astellas

Astellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative medical solutions that bring value and hope to patients and their families. Our mission is to address unmet medical needs and conduct business with ethics and integrity, improving the health of people worldwide.

Job Summary

The Medical Lead, Clinical Development Strategist will provide medical and strategic leadership in the planning, design, and conduct of clinical trials, enabling successful development, registration, and access of an asset to patients. This role is responsible for leading global development teams to design, implement, and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post-approval.

Key Responsibilities

  • Design and Execution of Clinical Development Plans
    • Accountable for design and final recommendations in clinical development plans for investigational products, soliciting input from colleagues in Regulatory Affairs, Commercial, and Medical Affairs.
    • Leads global development teams to design, implement, and conduct multi-phase development studies globally.
  • Leadership and Collaboration
    • Leads CGTD medical programs as part of post-marketing requirements.
    • Collaborates with Asset Lead, Clinical Operations Lead, and other stakeholders to ensure clinical development objectives are met.
  • Resource Planning and Budgeting
    • Plans resources required within the CGTD organization and with Asset Lead and Clinical Operations Lead to accomplish objectives in a timely and resource-efficient fashion.
    • Develops, recommends, and adheres to the clinical development budget.
  • Communication and Stakeholder Management
    • Motivates global development teams towards common goals of submitting approvable regulatory filings.
    • Keeps Asset Lead, project physicians, and management informed of clinical progress and critical medical issues.
  • Protocol Development and Review
    • Coordinates and authors protocol synopses, major protocol amendments, and communicates upcoming changes to the Medical Head of CGTD.
    • Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR, and clinical sections of regulatory submissions.
  • Health Economics and Outcomes Research
    • Incorporates Health Economics Outcomes Research requirements into protocol design.
  • Medical Monitoring and Safety
    • Oversees medical monitoring strategy and escalates potential safety signals and concerns to the Medical Head.
  • People Management
    • Serves as a people manager, monitoring employee performance, offering feedback, and encouraging them to reach their professional, corporate, divisional, and asset team goals.

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