**Position Objective:** The Scientific Program Manager will provide support to the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH).

**Duties and Responsibilities:**

+ Serve as a regulatory affairs management expert. Responsible for managing an Investigational New Drug (IND) application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use of investigational products in humans. **1**
+ Serve as an expert on all regulatory matters concerning the development of vaccines and monoclonal antibodies. This involves strategy, implementation, review processes, submissions and compliance with the FDA, National Institutes of Health (NIH) and international regulatory authority regulations. **2**
+ Provide recommendations to the office Director on optimal strategies to advance candidate products to the clinic. **3**