Clinical Development Specialist

1 month ago


Markham, Ontario, Canada Astellas Pharma Inc. Full time

**Clinical Scientist Job Description**

At Astellas Pharma Inc., we are seeking a highly skilled Clinical Scientist to join our team. As a key member of our clinical development team, you will be responsible for leading the development of clinical trials from initial study design to regulatory submissions.

**Key Responsibilities:**

  • Develop and execute clinical trial plans, including protocol development, investigator brochures, CRFs, informed consents, and clinical study reports.
  • Provide expertise to cross-functional teams to synthesize and contextualize data for timely decision-making.
  • Serve on the clinical sub-team and support the preparation of clinical development plans, site identification, and management.
  • Perform medical monitoring activities, including reviewing, analyzing, and triaging patient data, and generating reports.
  • Lead working groups and sub-team initiatives in support of protocol, disease area, or clinical development plans.

**Requirements:**

We are looking for a highly motivated and experienced individual with a strong background in clinical research and development. The ideal candidate will have:

  • An advanced degree in a relevant scientific discipline, such as health sciences or clinical disciplines.
  • 7-10 years of experience in clinical research and development, including experience with regulatory agencies.
  • Strong computer skills, including MS Office Suite and industry-standard software.
  • Excellent collaboration and interpersonal communication skills.

**Benefits:**

Astellas Pharma Inc. offers a competitive compensation package, including medical, dental, and vision insurance, generous paid time off, and a company-matched retirement savings plan.



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