Medical Lead for Clinical Development

4 weeks ago

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

As 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 medically qualified) with completion of residency in Ophthalmology with active or prior Board Certification. The ideal candidate will have at least 8 years of relevant experience in drug development in a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute. The successful candidate will have a proven record of being a successful medical leader and in study design, with excellent writing skills and experience managing drug development programs.

Key Responsibilities

• Lead 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.
• Develop and recommend clinical development plans in conjunction with Asset Lead.
• Acquire public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.
• Negotiate milestones and ensure clinical development objectives are met in conjunction with Asset Lead.
• Plan for resources required both within the CGTD organization and in conjunction with the Asset Lead and the Clinical Operations Lead (COL) to accomplish the 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 the common goal of submitting approvable regulatory filings in conjunction with Asset Lead.
• Keep Asset Lead, other project physicians and scientists, and management informed of clinical progress and any critical medical issues and 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 that 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's 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.
• 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 of 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.

  • Medical Lead for Clinical Development

    4 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, Clinical Development

    4 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

    4 weeks 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 Director, Clinical Development

    1 month 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...

  • Clinical Safety Monitoring Lead

    5 days ago

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

    Senior Manager, Clinical Safety Monitoring Opportunity at Everest Clinical Research Services IncWe are seeking a seasoned professional to lead our Clinical Safety Monitoring functional area. As a Senior Manager, you will be responsible for providing strategic leadership and guidance to ensure the successful execution of clinical trials.About Us:Everest...

  • Clinical Data Management Lead

    2 weeks ago

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

    Job OverviewWe are seeking a highly skilled and experienced Clinical Data Management Lead to join our team at Everest Clinical Research Services Inc.About the RoleThe successful candidate will be responsible for overseeing all aspects of clinical data management, ensuring high-quality deliverables and timely project execution. This is a senior-level position...

  • Senior Manager, Clinical Safety Monitoring Lead

    4 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...

  • Clinical Trial Web Application Developer

    4 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 wide range of clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled Clinical Trial Web Application Developer to join our team in Toronto, Ontario, Canada.Key Responsibilities:Design,...

  • Data Analysis Lead for Clinical Trials

    1 week ago

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

    Job Summary: As a Senior Statistical Programmer I at Everest Clinical Research Services Inc, you will be responsible for leading efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work. You will lead assigned projects by applying...

  • Senior Clinical Writer

    3 weeks ago

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

    Welcome to Everest Clinical Research Services Inc, a leading provider of clinical research solutions. We are seeking a highly skilled Senior Clinical Writer to join our team.About the Role:We are looking for an experienced medical writer to lead the preparation of clinical documents, including clinical study protocols, CSRs, DSURs, and integrated summaries....

  • Clinical Trials IWRS System Developer

    1 week ago

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

    About Everest Clinical Research Services IncEverest Clinical Research Services Inc is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.We serve some of the best-known companies and work with many of the most...

  • Senior Clinical Research Project Coordinator

    4 weeks ago

    Markham, Ontario, Canada Everest Clinical Research Full time

    Everest Clinical Research is a leading global contract research organization (CRO) providing a wide range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our team serves some of the world's most renowned companies and works with innovative drugs, biologics, and medical devices in development...

  • Medical Writer

    4 weeks ago

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

    Job Title: Medical WriterEverest Clinical Research Services Inc is seeking a skilled Medical Writer to join our team. As a Medical Writer, you will be responsible for creating high-quality clinical documents and scientific publications.Key Responsibilities:Work closely with project team members to achieve project milestones.Perform quality control procedures...

  • Clinical Safety Data Associate I

    1 month ago

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

    Job Title: Clinical Safety Data AssociateEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled and customer-focused individual to join our team as a Clinical Safety Data...

  • Medical Director, Clinical Research and Development

    6 days ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    OverviewAstellas Pharma Inc. is a leading pharmaceutical company seeking a highly skilled Medical Director to lead its Clinical Research and Development team.

  • Senior Medical Content Specialist

    5 days ago

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

    Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries.We are seeking a highly skilled Senior Medical Content Specialist to join our team in Toronto, Ontario, Canada. As a key member of our medical writing...

  • Medical Director, Clinical Research and Development

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Medical Lead to join our team at Astellas Pharma Inc. in this exciting opportunity to lead clinical development programs for ophthalmic therapeutics.

  • Clinical Trial Web Application Developer

    4 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 broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.We are seeking a highly skilled and customer-focused Clinical Trial Web Application Developer to join our winning team in...

  • Senior Clinical Data Manager

    1 month ago

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

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

  • Clinical Trials IWRS Monitor

    4 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 pharmaceutical, biotechnology, and medical device industries. We serve some of the world's most renowned companies and work with innovative drugs, biologics, and medical devices in development.We are seeking a skilled...