Current jobs related to Medical Lead, Clinical Development - Markham, Ontario - Astellas Pharma Inc.

  • Medical Lead Clinical Development

    3 weeks ago

    Markham, Ontario, Canada Astellas Full time

    Join Astellas as a Medical Lead in Clinical DevelopmentAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are committed to addressing unmet medical needs and conducting our business with ethics and integrity.This role is based in Northbrook, Illinois, with the...

  • Medical Lead Clinical Development

    1 month ago

    Markham, Ontario, Canada Astellas Full time

    Join Astellas as a Medical Lead in Clinical DevelopmentAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are committed to addressing unmet medical needs and conducting our business with ethics and integrity.This role is based in Northbrook, Illinois, with the...

  • Medical Lead Clinical Development

    1 month ago

    Markham, Ontario, Canada Astellas Full time

    Join Astellas as a Medical Lead in Clinical DevelopmentAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are committed to addressing unmet medical needs and conducting our business with ethics and integrity.This role is based in Northbrook, Illinois, with the...

  • Medical Lead Clinical Development

    1 month ago

    Markham, Ontario, Canada Astellas Full time

    Join Astellas as a Medical Lead in Clinical DevelopmentAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are committed to addressing unmet medical needs and conducting our business with ethics and integrity.This role is based in Northbrook, Illinois, with the...

  • Medical Lead Clinical Development

    3 weeks ago

    Markham, Ontario, Canada Astellas Full time

    Join Astellas as a Medical Lead in Clinical DevelopmentAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are committed to addressing unmet medical needs and conducting our business with ethics and integrity.This role is based in Northbrook, Illinois, with the...

  • Medical Lead Clinical Development

    1 month ago

    Markham, Ontario, Canada Astellas Full time

    Join Astellas as a Medical Lead in Clinical DevelopmentAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are committed to addressing unmet medical needs and conducting our business with ethics and integrity.This role is based in Northbrook, Illinois, with the...

  • Medical Lead for Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    ResponsibilitiesAs a Medical Lead for Clinical Development, you will be accountable for designing and finalizing recommendations in clinical development plans for investigational products, soliciting input and review from colleagues in Regulatory Affairs, Commercial, and Medical Affairs, Manufacturing, Clinical Pharmacology, Statistics, Health Economics and...

  • Medical Lead for Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryAs a Medical Lead for Clinical Development at Astellas Pharma Inc., you will be responsible for leading the global development team to design, implement, and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval. This role requires a medical degree (or...

  • Medical Lead, Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryAs a Medical Lead, Clinical Development at Astellas Pharma Inc., you will be responsible for leading the global development team to design, implement, and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval. You will also be accountable for execution and...

  • Medical Lead for Clinical Development

    1 week ago

    Markham, Ontario, Canada Astellas Full time

    Astellas Pharma Inc. is a pharmaceutical company that conducts business in over 70 countries worldwide. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.The Medical Lead will provide medical and strategic leadership in the planning, design, and conduct of clinical trials to enable...

  • Medical Lead, Clinical Development Strategist

    2 months ago

    Markham, Ontario, Canada Astellas Full time

    About AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative medical solutions that bring value and hope to patients and their families. Our mission is to address unmet medical needs and conduct business with ethics and integrity, improving the health of people worldwide.Job SummaryThe Medical Lead, Clinical...

  • Medical Lead, Clinical Development Strategist

    2 months ago

    Markham, Ontario, Canada Astellas Full time

    About AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative medical solutions that bring value and hope to patients and their families. Our mission is to address unmet medical needs and conduct business with ethics and integrity, improving the health of people worldwide.Job SummaryThe Medical Lead, Clinical...

  • Medical Director, Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Full time

    Astellas Pharma Inc. is a pharmaceutical company with a strong commitment to developing innovative therapies for patients. We are driven to deliver effective new medicines to patients and physicians, and we are seeking a talented Medical Lead to join our team.The Medical Lead will provide medical and strategic leadership in the planning, design, and conduct...

  • Medical Director, Clinical Development

    1 month ago

    Markham, Ontario, Canada Astellas Full time

    About the RoleAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are seeking a highly skilled Medical Lead to join our Clinical Development team in Northbrook, Illinois.Key ResponsibilitiesProvide medical and strategic leadership in the planning, design, and...

  • Medical Director, Clinical Development

    1 month ago

    Markham, Ontario, Canada Astellas Full time

    About the RoleAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. We are seeking a highly skilled Medical Lead to join our Clinical Development team in Northbrook, Illinois.Key ResponsibilitiesProvide medical and strategic leadership in the planning, design, and...

  • Medical Director, Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe are seeking a highly experienced Medical Director to lead our clinical development team in the design, implementation, and execution of clinical trials. The successful candidate will have a strong background in ophthalmology and a proven track record of leading successful drug development programs.Key ResponsibilitiesDesign and implement...

  • Medical Director, Clinical Development

    4 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe 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 ResponsibilitiesLead global...

  • Medical Director, Clinical Development

    4 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe 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 ResponsibilitiesLead global...

  • Senior Manager, Clinical Safety Monitoring Lead

    2 weeks ago

    Markham, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a range of clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled and experienced Senior Manager, Clinical Safety Monitoring to join our team in Toronto, Ontario, Canada.Key...

  • Medical Director, Clinical Development

    3 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe 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 ResponsibilitiesLead the global...

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.