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Medical Lead, Clinical Development

2 months ago

Markham, Ontario, Canada Astellas Pharma Inc. Full time
Job Summary

Astellas Pharma Inc. is seeking a highly experienced and skilled Medical Lead, Clinical Development to join our team. As a key member of our Clinical Development organization, you will be responsible for leading the design, implementation, and execution of clinical development plans for our investigational products.

Key Responsibilities
  • Lead Clinical Development Teams: Oversee the development of clinical development plans, protocols, and study reports to support regulatory submissions and post-approval filings.
  • Design and Implement Studies: Collaborate with cross-functional teams to design and implement multi-phase development studies globally to support regulatory submissions.
  • Manage Clinical Programs: Lead clinical programs, including post-marketing requirements, and ensure timely and successful execution.
  • Develop and Manage Budgets: Collaborate with Clinical Operations to develop and manage clinical development budgets.
  • Communicate with Stakeholders: Communicate clinical progress and critical medical issues to Asset Leads, project physicians, and management.
  • Provide Medical Expertise: Provide medical expertise and review of clinical documents, including protocols, IBs, study reports, and regulatory submissions.
  • Manage Teams: Serve as a people manager, monitoring employee performance, providing feedback, and encouraging professional growth.
Requirements
  • Medical Degree: Medical degree (or medically qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
  • Experience: At least 8 years of relevant experience in drug development in a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute.
  • Leadership Experience: Proven record of being a successful medical leader and in study design.
  • Communication Skills: Excellent writing skills with experience writing regulatory documents and attending Health Authority interactions.
  • Management Experience: Experience managing drug development programs, designing and planning clinical studies, and managing one or more direct reports.
Preferred Qualifications
  • Therapeutic Area Experience: Experience working in at least one other therapeutic area outside of ophthalmology.
  • Cell or Gene Therapy Experience: Experience working in cell or gene therapy drug development.