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Medical Lead, Clinical Development

2 months ago

Markham, Ontario, Canada Astellas Pharma Inc. Full time
Job Title: Medical Lead, Clinical Development

About the Role:

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 filing of successful regulatory submissions and supplemental filings post-approval.

Key Responsibilities:

  • Lead the global development team to design, implement, and conduct multi-phase development studies globally.
  • Accountable for execution and delivery of the clinical development plan in conjunction with the Asset Lead.
  • Acquire public knowledge of present and future competitor products and their impact on internal medical and commercial strategy.
  • Negotiate milestones and ensure clinical development objectives are met in conjunction with the Asset Lead.
  • Plan for resources required within the CGTD organization and in conjunction with the Asset Lead and Clinical Operations Lead to accomplish objectives in a timely and resource-efficient fashion.
  • Responsible for developing, recommending, and adhering to the clinical development budget in collaboration with Clinical Operations.
  • Motivate global development team towards submitting approvable regulatory filings in conjunction with the Asset Lead.
  • Keep the Asset Lead, other project physicians and scientists, and management informed of clinical progress and critical medical issues, especially the emerging safety profile.
  • Coordinate and author protocol synopses, major protocol amendments, and communicate upcoming changes to the Medical Head of CGTD.
  • Provide input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR, and clinical sections of regulatory submissions.
  • May plan and convene clinical expert panel meetings and advisory boards to provide input into drug development plans.
  • Present to senior management and external audiences various medical aspects of drug development, including milestones, strategies, and recent data, and anticipate obstacles to or changes to approved plans.
  • Incorporate Health Economics Outcomes Research requirements into protocol design.
  • Oversee medical monitoring strategy and escalate potential safety signals and concerns to the Medical Head.
  • 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 (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 (NCI, NIH, Academic Research groups, etc.) with at least 5 years working in clinical development.
  • 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 both 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 as well as medical terminology, drug development, clinical trials, and clinical research.
  • 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, plus national holidays including Heritage Days, and Summer and Winter Breaks.
  • 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.