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Medical Lead, Clinical Development

2 months ago

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

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

Key Responsibilities
  • Lead Clinical Development Teams: Oversee the development of clinical development plans, protocols, and study reports to support regulatory submissions and post-approval filings.
  • Design and Implement Studies: Collaborate with cross-functional teams to design and implement multi-phase development studies globally to support regulatory submissions.
  • Medical Program Leadership: Lead clinical development programs, including post-marketing requirements, and ensure timely and successful execution.
  • Resource Planning: Plan and manage resources, including employees and contractors, to accomplish clinical development objectives in a timely and resource-efficient manner.
  • Budget Development: Collaborate with Clinical Operations to develop and recommend clinical development budgets.
  • Team Motivation: Motivate and lead global development teams towards common goals, including submitting approvable regulatory filings.
  • Communication: Communicate clinical progress and critical medical issues to Asset Leads, project physicians, and management.
  • Protocol Synopses: Coordinate and author protocol synopses, major protocol amendments, and communicate upcoming changes to the Medical Head of Clinical Development.
  • Document Review: Provide input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR, and clinical sections of regulatory submissions.
  • Expert Panel Meetings: Plan and convene clinical expert panel meetings and advisory boards to provide input into drug development plans.
  • Presentation: Present medical aspects of drug development to senior management and external audiences, including milestones, strategies, and recent data.
  • Health Economics: Incorporate Health Economics Outcomes Research requirements into protocol design.
  • Safety Monitoring: Oversee medical monitoring strategy and escalate potential safety signals and concerns to the Medical Head.
  • People Management: Serve as a people manager to monitor employee performance, offer feedback, and encourage them to reach their professional, corporate, divisional, and asset team goals.
Requirements
  • Medical Degree: Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
  • Experience: At least 8 years of relevant experience in drug development in a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute.
  • Leadership Experience: Proven record of being a successful medical leader and in study design.
  • Writing Skills: Excellent writing skills with experience writing regulatory documents and attending Health Authority interactions.
  • Program Management: Experience managing drug development programs.
  • Study Design: Experience designing and planning clinical studies to produce timely and high-quality data.
  • Matrix Management: Proven ability to get results in a matrixed management environment.
  • Regulatory Knowledge: Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as medical terminology, drug development, clinical trials, and clinical research.
  • People Management: Experience managing one or more direct reports.
Preferred Qualifications
  • Therapeutic Area Experience: Experience working in at least one other therapeutic area outside of ophthalmology.
  • Cell or Gene Therapy: Experience working in cell or gene therapy drug development.
Benefits
  • Medical Insurance: Medical, Dental, and Vision Insurance.
  • Paid Time Off: Generous Paid Time Off options, including Vacation, Sick time, plus national holidays.
  • RRSP: RRSP.
  • Life Insurance: Company-paid life insurance.
  • Bonus and Incentive: Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions.
  • Long Term Incentive Plan: Long Term Incentive Plan for eligible positions.
  • Referral Bonus: Referral bonus program.