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The key responsibilities will be:

  • Lead development and implementation of translational medicine strategies for Oncology compounds 
  • Apply multiple genomic and biochemical technology platforms to demonstrate target engagement, develop and implement patient selection and diagnostic strategies.
  • Partner with clinical and discovery groups to create high quality biomarker strategies in the clinic
  • Implement potential novel bioanalytical platforms and introduce new ways to incorporate biomarkers into clinical program designs.
  • Design and perform experiments to elucidate resistance mechanisms that can be developed into biomarkers and new therapeutics. 
  • Author the translational research and CDx portions in key clinical documents including protocol/informed consent, Clinical study Report, Investigators Brochure, etc.  Contribute the scientific and technical sections as it relates to translational science and CDx in key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). 
  • Provide hands-on clinical trial support, including sample management, lab work, and report generation. 
  • Function as an internal expert in oncology biomarkers and precision medicine and actively educate other team members through knowledge sharing.
  • Present and report data in external meetings and publications.

Level commensurate with experience.

Qualifications:

  • B.S, M.S. and/or Ph.D. in Cancer Biology, Cell Biology, Molecular Biology or related field with 6-8+ (Ph.D), 12-14+ (M.S), or 14-16+ (B.S) years of experience in developing and implementing  translational medicine strategies, and a track record of success in the pharma industry.
  • Strong scientific background in tumor biology and expertise in immuno-oncology, epigenetics, or tumor immune microenvironment is preferred.
  • Demonstrated technical excellence and expertise in Translational medicine; including hands-on experience taking small molecules and/or biologics through preclinical to clinical development.
  • Companion diagnostics development experience is a plus
  • Experience in analysis of large datasets and knowledge of biostatistics
  • Experience in the development and utilization of biomarkers, various technologies/platforms ( –omics technologies, immunohistochemistry and  immunoassays, etc.).
  • Effectively work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites/KOLs
  • Organization, orientation to details, and effective time management with an ability to adapt to changing priorities 
  • Excellent interpersonal and communication skills.
  • Must be able to work effectively on multiple oncology programs in a fast dynamic environment.

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