Medical Director, Clinical Development

1 month ago

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

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

Key Responsibilities
  • Lead the global development team to design, implement, and conduct multi-phase development studies to support regulatory submissions and post-approval filings.
  • Develop and recommend clinical development budgets in collaboration with Clinical Operations.
  • Provide medical input and review of clinical documents, including protocols, IBs, study reports, and regulatory submissions.
  • Coordinate and author protocol synopses, major protocol amendments, and communicate changes to the Medical Head of CGTD.
  • Present medical aspects of drug development to senior management and external audiences.
  • Oversee medical monitoring strategy and escalate potential safety signals to the Medical Head.
Requirements
  • Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
  • At least 8 years of relevant experience in drug development in a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute.
  • Proven record of being a successful medical leader and in study design.
  • Excellent writing skills with experience writing regulatory documents and attending Health Authority interactions.
  • Experience managing drug development programs and designing clinical studies.
Preferred Qualifications
  • Experience working in at least one other therapeutic area outside of ophthalmology.
  • Experience working in cell or gene therapy drug development.
What We Offer
  • Medical, Dental, and Vision Insurance.
  • Generous Paid Time Off options, including Vacation, Sick time, and national holidays.
  • RRSP.
  • Company-paid life insurance.
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions.
  • Long Term Incentive Plan for eligible positions.
  • Referral bonus program.

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