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