Gaithersburg, MD

Job Description

My biotech client is expanding and seeks a Preclinical Immunologist.  The ideal candidate will take on the following tasks:

  • Develop preclinical strategies to take leads from candidate selection to successful IND and beyond
  • Apply knowledge and practical experience of immunology and immunotoxicology
  • Support submissions to worldwide health authorities and communicate with FDA and regulatory agencies to resolve nonclinical issues
  • Write and review nonclinical safety documentation (including IBs, IMPDs, INDs and BLAs)
  • Serve as study monitor for the design, conduct, and reporting of nonclinical Pharmacology and Toxicology studies performed at CROs to ensure a quality final product

 The ideal candidate will possess the following qualities:

  • PhD and experience with human immunology and preclinical models
  • Experience with immunological and molecular principles including relevant techniques (multicolor flow cytometry)
  • Coordinate, organize, analyze, and document nonclinical studies
  • Ability to synthesize, organize, and analyze diverse, multidisciplinary data sets
  • Proficiency with MS Office and common laboratory software 
  • Working knowledge of regulatory guidelines relevant to preclinical development is a plus
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