Clinical Research Scientist

3 weeks ago

Markham, Ontario, Canada Astellas Full time

Clinical Scientist

Are you eager to contribute to a diverse team focused on pioneering therapies for patients? At Astellas, we are dedicated to the advancement and delivery of innovative and effective medicines for healthcare providers and patients alike.

Astellas Pharma Inc. operates in over 70 countries globally, committed to transforming groundbreaking science into medical solutions that provide value and hope to patients and their families. Our unwavering focus on addressing unmet medical needs, coupled with our commitment to ethical practices, allows us to enhance the health of individuals worldwide. For further insights about Astellas, please visit our official website.

This role is available for remote work within Canada. We encourage candidates interested in remote opportunities to consider applying.

Key Responsibilities:

  • Oversee and manage all aspects of current and upcoming clinical trials, including the development of protocols, investigator brochures, case report forms (CRFs), informed consent documents, and clinical study reports.
  • Provide expertise to cross-functional teams to synthesize and contextualize data, facilitating discussions and timely decision-making.
  • Participate in the clinical sub-team alongside the Global Medical Lead (GML), Operations Lead, and Medical Monitor, supporting the preparation of clinical development plans and site management.
  • Conduct medical monitoring activities under the guidance of the study physician, including the review and analysis of patient data.
  • Lead working groups and sub-team initiatives independently in support of clinical protocols and development plans.
  • Collaborate with the GML in preparing for Health Authority meetings and addressing inquiries.
  • Assist in preparing analyses for Data Monitoring Committees (DMC), Data Safety Monitoring Boards (DSMB), or regulatory submissions.
  • Deliver training at investigator meetings and site initiation visits, partnering with Clinical Operations and Medical Affairs to ensure appropriate enrollment in clinical studies.
  • Engage with potential and current sites through various meetings and conferences.
  • Exhibit expertise in study data review and analysis, providing clinical input into statistical planning and data interpretation.
  • Support the publication of data, including manuscripts and presentations, related to disease or technology.
  • Work closely with operations for site feasibility, trial setup, and monitoring.
  • May lead contract execution for investigator meetings and advisory boards.
  • Foster strategic partnerships with Key External Experts (KEEs).
  • Serve as a key partner in assessing candidates within discovery, identifying opportunities and risks associated with future development strategies.
  • May represent development in clinical assessments for due diligence of new assets for potential in-licensing and acquisition.
  • Support strategic initiatives related to assigned molecules, therapeutic areas, or portfolios as needed.
  • Perform additional duties or special projects as required.

Organizational Context:

  • This position reports to the Primary Focus Medical Head or other leads based on the designated program.
  • This role is typically an individual contributor position, with the possibility of direct reports depending on the scope and complexity of assigned development programs.

  • Clinical Research Scientist

    3 weeks ago

    Markham, Ontario, Canada Astellas Full time

    Clinical Scientist Are you interested in contributing to a diverse team dedicated to pioneering therapies for patients? At Astellas, we are committed to creating and delivering innovative and effective medications for healthcare providers and patients alike. Astellas Pharma Inc. operates in over 70 countries globally, focusing on transforming innovative...

  • Clinical Research Assistant

    5 days ago

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

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

  • Clinical Research Assistant

    3 days ago

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

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

  • Statistical Programmer

    5 days ago

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

    Job SummaryWe are seeking a highly skilled Statistical Programmer to join our team at Everest Clinical Research Services Inc. As a key member of our clinical research team, you will be responsible for compiling and reviewing dataset specifications, annotated patient Case Report Forms, and other related programming documentation to ensure compliance with...

  • Statistical Programmer

    3 days ago

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

    Job SummaryWe are seeking a highly skilled Statistical Programmer to join our team at Everest Clinical Research Services Inc. As a key member of our clinical research team, you will be responsible for compiling and reviewing dataset specifications, annotated patient Case Report Forms, and other related programming documentation to ensure compliance with...

  • Statistical Programmer

    3 days ago

    Markham, Ontario, Canada Everest Clinical Research Services Inc. Full time $63,453 - $68,500

    Job SummaryWe are seeking a highly skilled Statistical Programmer to join our team at Everest Clinical Research Services Inc.. As a key member of our clinical research team, you will be responsible for compiling and reviewing dataset specifications, annotated patient Case Report Forms, and other related programming documentation to ensure compliance with...

  • Statistical Programmer

    4 days ago

    Markham, Ontario, Canada Everest Clinical Research Services Inc. Full time $63,453 - $68,500

    Job SummaryWe are seeking a highly skilled Statistical Programmer to join our team at Everest Clinical Research Services Inc.. As a key member of our clinical research team, you will be responsible for compiling and reviewing dataset specifications, annotated patient Case Report Forms, and other related programming documentation to ensure compliance with...

  • Clinical Research Contracts Specialist

    5 days ago

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

    About the RoleWe are seeking a highly skilled and experienced Clinical Research Contracts Specialist to join our team at Everest Clinical Research Services Inc. As a key member of our contracts team, you will be responsible for negotiating and managing clinical trial agreements with investigative sites located in the US and Canada.Key...

  • Clinical Research Scientist, Oncology

    3 days ago

    Markham, Ontario, Canada Astellas Full time

    About the RoleAstellas is seeking a highly skilled Clinical Scientist to join our Oncology team. As a key member of our development team, you will play a critical role in the development of innovative therapies for patients.Key ResponsibilitiesDesign, implement, and monitor clinical studies to support the development of new cancer therapies.Collaborate with...

  • Clinical Research Scientist, Oncology

    5 days ago

    Markham, Ontario, Canada Astellas Full time

    About the RoleAstellas is seeking a highly skilled Clinical Scientist to join our Oncology team. As a key member of our development team, you will play a critical role in the development of innovative therapies for patients.Key ResponsibilitiesDesign, implement, and monitor clinical studies to support the development of new cancer therapies.Collaborate with...

  • Clinical Data Manager

    3 days ago

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

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

  • Clinical Trial Coordinator

    5 days ago

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

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

  • Clinical Data Manager

    5 days ago

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

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

  • Clinical Trial Coordinator

    3 days ago

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

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

  • Clinical Development Scientist

    6 hours ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    About the RoleAstellas Pharma Inc. is seeking a highly skilled Clinical Development Scientist to join our team. As a key member of our clinical development team, you will be responsible for leading the development and execution of clinical trials from protocol development to study close-out.Key ResponsibilitiesProtocol Development: Develop and maintain...

  • Clinical Research Scientist

    3 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Key Responsibilities:Accountable for overseeing all aspects of ongoing and upcoming clinical trials, including the formulation of protocols, investigator brochures, case report forms (CRFs), informed consent documents, and clinical study reports, as well as reviewing trial documents and study analyses.Provide specialized knowledge to multidisciplinary team...

  • Lead Clinical Safety Associate

    3 weeks ago

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

    Senior Clinical Trial Drug Safety AssociateEverest Clinical Research Services Inc is in search of a committed Senior Clinical Trial Drug Safety Associate. In this pivotal role, you will be instrumental in safeguarding the health and safety of participants in clinical trials. Your duties will encompass guiding junior staff, analyzing safety data, aiding in...

  • Clinical Data Manager

    6 hours ago

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

    About Everest Clinical Research Services IncEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. With a strong foundation as a statistical and data management center of excellence, we have successfully...

  • Clinical Research Scientist

    3 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Key Responsibilities:Oversee and take ownership of all tasks associated with ongoing and upcoming clinical trials, including the creation of protocols, investigator brochures, case report forms (CRFs), informed consent documents, and clinical study reports.Provide specialized knowledge to multidisciplinary team members to integrate and interpret data,...

  • Clinical Research Scientist

    3 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Key Responsibilities:Accountable for overseeing all activities related to ongoing and upcoming clinical trials, including the development of protocols, investigator brochures, case report forms (CRFs), informed consent documents, and clinical study reports.Provides specialized knowledge to cross-functional teams to integrate and contextualize data,...