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Medical Lead for Clinical Development

2 months ago

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

We are seeking a highly skilled Medical Lead for Clinical Development to join our team at Astellas Pharma Inc. This is a critical role that requires a strong medical background, leadership skills, and experience in clinical development.

Key Responsibilities
  • Design and implement clinical development plans for investigational products, collaborating with cross-functional teams to ensure successful regulatory submissions.
  • Lead global development teams to design, implement, and conduct multi-phase development studies, ensuring timely and high-quality data.
  • Develop and recommend clinical development budgets, working closely with Clinical Operations to ensure resource allocation.
  • Motivate global development teams to achieve common goals, including submitting approvable regulatory filings.
  • 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.
Requirements
  • Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology and 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, with excellent writing skills and experience writing regulatory documents.
  • Experience managing drug development programs, designing and planning clinical studies, and getting results in a matrixed management environment.
  • Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines.
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.