The Office of New Drugs (OND) is recruiting to fill the position of Deputy Office Director, Office of Immunology and Inflammation (OII). OND ensures that safe and effective drugs and biologics are available to the American people. OND provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. Within OND, OII consists of six review divisions: The Division of Rheumatology and Transplant Medicine, the Division of Pulmonology, Allergy and Critical Care, the Division of Gastroenterology, the Division of Hepatology and Nutrition, the Division of Dermatology and Dentistry and the Division of Pharm-Tox for Immunology and Inflammation. The Immediate Office oversees the development, review, and regulation of applications for drug and biologic products reviewed in these divisions. As the primary advisor to the Office Director for OII, the incumbent is expected to provide leadership, technical and administrative direction to scientific and regulatory review staff engaged in review and evaluation of IND, NDA, and BLA applications; provides scientific, clinical, regulatory, administrative and technical oversight for medical and scientific decisions and recommendations made in connection with the review and evaluation of drugs intended to treat immunologic and inflammatory disorders. The selected candidate will possess a demonstrated track record of scientific leadership, program development, stakeholder engagement, and knowledge management with respect to immunology and inflammation; demonstrate experience collaborating across scientific disciplines and medical specialties; have substantial management and supervisory experience; possess a strong commitment to public health; and must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical school must be certified by the Education Commission for Foreign Medical Graduates (ECFMG). Candidates must be U.S. citizens.