Clinical Scientist, Oncology Specialist

5 days ago


Markham, Ontario, Canada Astellas Full time
About the Role

We are seeking a highly skilled Clinical Scientist to join our Oncology team at Astellas. As a key member of our development team, you will play a critical role in the development of clinical strategies for assigned modalities or indications within the division.

Key Responsibilities
  • Develop and implement clinical strategies for assigned development programs, working closely with the Global Medical Lead, Operations Lead, and Asset Lead.
  • Design, implement, monitor, and analyze clinical studies, ensuring compliance with regulatory requirements and company standards.
  • Provide expertise to cross-functional team members, synthesizing and contextualizing data to facilitate timely decision-making.
  • Serve on the clinical sub-team, supporting preparation of clinical development plans, site identification and management, and DESC meetings.
  • Perform medical monitoring activities, reviewing and analyzing patient data, generating reports, and providing clinical input into statistical planning, data analysis, and interpretation.
  • Collaborate with the Global Medical Lead and Product Responsible Person to prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
  • Develop and deliver training at investigator meetings and site initiation visits, and partner with Clinical Operations and Medical Affairs to enable appropriate enrollment into clinical studies or registries.
  • Support engagement with potential and current sites, including SIVs, investigator meetings, conferences, steering committee, and advisory board meetings.
Requirements
  • Strong clinical development expertise, with a focus on oncology.
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
  • Proven ability to design, implement, and analyze clinical studies, with a strong understanding of regulatory requirements and company standards.
  • Ability to provide clinical input into statistical planning, data analysis, and interpretation, and to develop and deliver training at investigator meetings and site initiation visits.
  • Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.



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