Medical Lead for Clinical Development

1 week ago

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

We are seeking a highly experienced Medical Lead for Clinical Development to join our team at Astellas Pharma Inc. This role will be responsible for leading the global development team to design, implement, and conduct multi-phase development studies to support regulatory submissions and post-approval filings.

Key Responsibilities
  • Lead the global development team to design, implement, and conduct multi-phase development studies to support regulatory submissions and post-approval filings.
  • Develop and recommend clinical development plans in conjunction with 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 Asset Lead.
  • Plan resources required within the CGTD organization and in conjunction with Asset Lead and Clinical Operations Lead to accomplish objectives in a timely and resource-efficient fashion.
  • Develop, recommend, and adhere to the clinical development budget in collaboration with Clinical Operations.
  • Motivate global development team towards submitting approvable regulatory filings in conjunction with Asset Lead.
  • Keep Asset Lead, project physicians, and management informed of clinical progress and critical medical issues, especially emerging safety profiles.
  • 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 medical aspects of drug development to senior management and external audiences, 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 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.
  • 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.

  • Medical Lead, Clinical Development

    6 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job Title: Medical Lead, Clinical DevelopmentAbout 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...

  • Medical Lead, Clinical Development

    6 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job Title: Medical Lead, Clinical DevelopmentAbout 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...

  • Medical Lead, Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryAstellas 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 ResponsibilitiesLead...

  • Medical Lead, Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryAstellas 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 ResponsibilitiesLead...

  • Medical Lead for Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe 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 ResponsibilitiesDesign and implement clinical development plans for investigational products,...

  • Medical Lead for Clinical Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe 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 ResponsibilitiesDesign and implement clinical development plans for investigational products,...

  • Medical Lead, Clinical Development

    3 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryAstellas 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 ResponsibilitiesLead...

  • Medical Lead, Clinical Development

    3 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryAstellas 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 ResponsibilitiesLead...

  • Medical Lead, Clinical Development

    2 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe are seeking a highly skilled Medical Lead, Clinical Development to join our team at Astellas Pharma Inc. This is a critical role that will lead the development of clinical trials and ensure the successful submission of regulatory filings.Key ResponsibilitiesDesign and implement clinical development plans for investigational products,...

  • Medical Lead, Clinical Development

    2 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe are seeking a highly skilled Medical Lead, Clinical Development to join our team at Astellas Pharma Inc. This is a critical role that will lead the development of clinical trials and ensure the successful submission of regulatory filings.Key ResponsibilitiesDesign and implement clinical development plans for investigational products,...

  • Medical Lead, Clinical Development

    4 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe are seeking a highly skilled Medical Lead, Clinical Development to join our team at Astellas Pharma Inc. This is a critical role that will lead the development of clinical trials and ensure the successful submission of regulatory filings.Key ResponsibilitiesDesign and implement clinical development plans for investigational products,...

  • Medical Lead, Clinical Development

    4 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe are seeking a highly skilled Medical Lead, Clinical Development to join our team at Astellas Pharma Inc. This is a critical role that will lead the development of clinical trials and ensure the successful submission of regulatory filings.Key ResponsibilitiesDesign and implement clinical development plans for investigational products,...

  • Medical Lead for Clinical Development

    7 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe are seeking a highly skilled Medical Lead for Clinical Development to join our team at Astellas Pharma Inc. This is a critical role that requires a strong medical background, leadership skills, and experience in clinical development.Key ResponsibilitiesDesign and implement clinical development plans for investigational products, collaborating...

  • Medical Lead for Clinical Development

    7 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job SummaryWe are seeking a highly skilled Medical Lead for Clinical Development to join our team at Astellas Pharma Inc. This is a critical role that requires a strong medical background, leadership skills, and experience in clinical development.Key ResponsibilitiesDesign and implement clinical development plans for investigational products, collaborating...

  • Medical Lead, Clinical Development Strategist

    2 weeks 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 weeks 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

    4 days 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

    4 days 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...

  • Clinical Development Lead

    3 weeks ago

    Markham, Ontario, Canada Astellas Full time

    About the RoleAstellas is seeking a highly skilled Medical Lead to join our Clinical Development team. As a key member of our team, you will be responsible for providing medical and strategic leadership in the planning, design, and conduct of clinical trials.Key ResponsibilitiesDesign and Execution of Clinical Development Plans: Develop and implement...

  • Clinical Development Lead

    3 weeks ago

    Markham, Ontario, Canada Astellas Full time

    About the RoleAstellas is seeking a highly skilled Medical Lead to join our Clinical Development team. As a key member of our team, you will be responsible for providing medical and strategic leadership in the planning, design, and conduct of clinical trials.Key ResponsibilitiesDesign and Execution of Clinical Development Plans: Develop and implement...