Medical Lead for Clinical Development

17 hours 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 will lead the development of clinical programs and ensure the successful execution of clinical trials.

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.
  • Provide medical input and review of clinical documents, including protocols, IBs, study reports, and regulatory submissions.
  • Collaborate with Asset Lead and Clinical Operations to plan and execute clinical trials, ensuring compliance with ICH/GCP guidelines and regulatory requirements.
  • Communicate clinical progress and critical medical issues to senior management and external audiences, including Health Authority interactions.
  • 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, with excellent writing skills and experience writing regulatory documents.
  • Experience managing drug development programs, designing and planning clinical studies, and 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.
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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