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Clinical Biomarker Scientist

Cambridge, Massachusetts

Post Date: 12/11/2017 Job ID: 1671 Job Category: Clinical: Scientific

The Clinical Pharmacology Department is searching for a scientist experienced in the development and execution of biomarker strategies supporting clinical trials.

Job Responsibilities:
  • Provide biomarker expertise and guidance to program teams to design and implement scientifically driven clinical biomarker plan
  • Serve as single point of contact accountable for executing biomarker strategy, including planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery/reporting and final sample disposition)
  • Participate in the authoring of biomarker sections of clinical documents including Clinical Study Protocols, Informed Consent Forms and Laboratory Reference Manuals 
  • Ensure the timely and efficient delivery of all biomarker deliverables, in accordance with the appropriate quality standards and applicable regulations
  • Collaborate with clinical pharmacology and other functions to integrate clinical biomarker data with other data to support dose selection and future trial design
  • Collaborate with internal and external networks in the field of clinical biomarkers and keep up to date with emerging literature and science

  • Individual with a BS, MS, or Ph.D. degree in Biological Sciences or related fields
  • Minimum of 2 years of pharmaceutical industry experience in clinical biomarker plan design and implementation 
  • Understanding of drug discovery and development
  • Effective communication skills and the ability to influence, negotiate, and communicate with the project team

Preferred qualifications:
  • Prior biomarker-related experiences in the following therapeutic areas: GI, inflammatory diseases, metabolic disease, cardiovascular diseases, hematological diseases, or CNS
  • Publication record associated with clinical biomarker investigations

Anna Korelis

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