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Senior Scientist-PK - Now Hiring!

Senior Scientist-PK - Now Hiring!

AstellasNorthbrook, IL, United States
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Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at 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. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at  www.astellas.com .

The Role :

  • Responsible for the regulated bioanalytical assay development, validation and implementation of bioanalytical methods in the quantification of human biospecimens from clinical studies across multiple therapeutic areas / assets to support decision making.
  • Work in cross functional capacity to obtain clinical sample results to inform program strategy and clinical trial decisions.

Responsibilities

  • Serve as a subject matter expert for regulated bioanalysis across multiple modalities, and QA audits.
  • Serve as a bioanalytical lead in asset teams and clinical development for decision making (Go / No-go) from P0 through post marketing obligations.
  • Collaborate with stakeholders providing solutions to challenges and mitigating risk.
  • Manage the bioanalytical assay transfer / validation, data review, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance.
  • Provide technical expertise and guidance over the assay life cycle.
  • Contribute to regulatory submission documentation i.e., INDs, IBs, NDAs / BLAs
  • Ability to collaborate cross functionally within the research organization and clinical development across all regions.
  • Lead the identification and application of new technology assessments and utilization in human clinical trials
  • Keep current with all regulatory guidelines and technical innovations.
  • Follow and influence relevant Standard Operating Procedures and current bioanalytical regulatory guidelines.
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    Now Hiring • Northbrook, IL, United States