Director, Division of Rare Diseases and Medical Genetics

The Office of New Drugs (OND) is recruiting to fill the position of Director, Division of Rare Diseases and Medical Genetics (DRDMG).

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, the Division of Rare Diseases and Medical Genetics (DRDMG) is responsible for rare disease drug products, including inherited disorders. This individual will direct a team responsible for regulating and guiding IND development of rare disease drug programs and reviewing rare disease drug applications. This division is also responsible for providing direction and guidance across OND therapeutic divisions in support of rare disease drug development, regulation, and application review. In addition, the division works collaboratively with other FDA offices to enhance and coordinate rare disease drug regulation and development, and works with external stakeholders including academic, patient and family, and other stakeholder groups to facilitate and support drug development for rare diseases.

The DRDMG Directorship is a unique scientific leadership opportunity at the crossroads of drug development for rare diseases.

The selected candidate will possess a demonstrated track record of scientific leadership, program development, stakeholder engagement, and knowledge management with respect to rare diseases and medical genetics; experience collaborating across scientific disciplines and medical specialties; management and supervisory experience; and 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.

Interested candidates may direct any questions concerning the position to the OND External Recruitment Team at ond-employment@fda.hhs.gov. To apply, submit your cover letter and CV/resume to ond-employment@fda.hhs.gov. Please indicate that you are applying to source code: 20-025EG.