Medical Director, Clinical Development

4 weeks ago

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

We are seeking a highly skilled Medical Lead to join our Clinical Development team at Astellas Pharma Inc. As a Medical Lead, you will be responsible for leading the design, implementation, and conduct of multi-phase development studies globally to support regulatory submissions and post-approval filings.

Key Responsibilities
  • Lead the global development team to design, implement, and conduct clinical studies to support regulatory submissions and post-approval filings.
  • Develop and recommend clinical development plans in conjunction with Asset Lead.
  • Acquire public knowledge of competitor products and their impact on internal medical and commercial strategy.
  • Negotiate milestones and ensure clinical development objectives are met.
  • Plan resources required to accomplish objectives in a timely and resource-efficient fashion.
  • Develop and recommend clinical development budgets in collaboration with Clinical Operations.
  • Motivate global development teams towards common goals.
  • Keep Asset Lead and management informed of clinical progress and critical medical issues.
  • Coordinate and author protocol synopses, major protocol amendments, and communicate upcoming changes.
  • Provide medical review of clinical documents, including protocols, IBs, study reports, and statistical analysis plans.
  • May plan and convene clinical expert panel meetings and advisory boards.
  • Presents to senior management and external audiences on medical aspects of drug development.
Requirements
  • Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
  • At least 8 years 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.
  • Experience designing and planning clinical studies to produce timely and high-quality data.
  • Proven ability to get results in a matrixed management environment.
  • Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines.
  • Experience managing one or more direct reports.
Preferred Qualifications
  • Experience working in at least one other therapeutic area outside of ophthalmology.
  • Experience working in cell or gene therapy drug development.
Benefits
  • 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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