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FDA's Office of New Drugs
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Spotlight Preferred Member Company
FDA's Office of New Drugs
Maryland, United States (hybrid)
14 days ago

Description

The Office of New Drugs (OND) mission is to ensure 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. 

OND is recruiting to fill the position of Division Director, Division of Biomedical Informatics, Research, and Biomarker Development (DBIRBD). DBIRBD oversees OND scientific research programs to inform regulatory decision making; develops standards for review of safety databases; provides scientific leadership and technical advice concerning biomarkers and surrogate endpoints; collaborates with academic scientists, industry, patient groups, governmental partners and other stakeholders concerning biomarker and surrogate endpoint development. This position includes oversight of the Biomarker Qualification Program established in response to the 21st Century Cures Act which adds a new section 507 to the Federal Food and Drug Cosmetic Act. The position also provides oversight of the Innovative Science and Technology Approaches for New Drugs (ISTAND), a pilot program that will help expedite the development of promising therapeutics to address unmet medical needs. The DBIRBD Directorship represents a unique opportunity to accelerate and enable drug development through application of rigorous scientific evaluation of novel and promising methodologies that can be applied across broad therapeutic classes to improve efficiencies in clinical trial execution.

SALARY & BENEFITS 

  • Salary is commensurate with experience and expertise
  • Excellent federal government benefits package (health insurance, life insurance, retirement, etc.).
  • Relocation expenses and student loan repayment may be paid to eligible candidates. 

QUALIFICATIONS 

The selected candidate will be a leading expert on the development of biomarkers and surrogate endpoints and application of biomarkers/surrogates to facilitate clinical research, has a strong background in clinical translational research, possesses strong organizational and program development skills. Applicants must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical schools must be certified by the Education Commission for Foreign Medical Graduates. Candidates must be U.S. citizens and possess an active U.S. medical license.



Requirements

TO APPLY

Interested candidates may direct any questions concerning the position to OND’s Administrative Analysis Staff 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’re applying to source code: #23-013EG in the subject line.

Job Information

  • Job ID: 54365031
  • Workplace Type: Hybrid
  • Location:
    Maryland, United States
  • Company Name For Job: FDA's Office of New Drugs
  • Position Title: Division Director, Division of Biomedical Informatics, Research, and Biomarker Development
  • Job Function: Manager/Director
  • Setting: Federal Government
  • Job Type: Full-Time
  • Min Education: MD
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