Medical Director, Clinical Development

3 weeks 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 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 global development teams to design, implement, and conduct clinical studies to support regulatory submissions and post-approval filings.
  • Develop and execute clinical development plans in conjunction with Asset Leads.
  • Acquire and maintain public knowledge of competitor products and their impact on internal medical and commercial strategies.
  • Negotiate milestones and ensure clinical development objectives are met in conjunction with Asset Leads.
  • Plan and manage resources required for clinical development, including employees and contractors.
  • Develop and recommend clinical development budgets in collaboration with Clinical Operations.
  • Motivate global development teams towards common goals of submitting approvable regulatory filings.
  • Keep Asset Leads, project physicians, and management informed of clinical progress and critical medical issues.
  • Coordinate and author protocol synopses, major protocol amendments, and communicate changes to Medical Heads.
  • Provide medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR, and clinical sections of regulatory submissions.
  • Plan and convene clinical expert panel meetings and advisory boards to provide input into drug development plans.
  • Present medical aspects of drug development to senior management and external audiences.
  • Incorporate Health Economics Outcomes Research requirements into protocol design.
  • Oversee medical monitoring strategy and escalate potential safety signals and concerns to Medical Heads.
  • Serve as a people manager to monitor employee performance, offer feedback, and encourage professional growth.
Requirements
  • Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
  • Willingness to work across different ophthalmic indications.
  • 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.
  • 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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