The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs. The Office of New Drugs (OND) is a super office within the Center for Drug Evaluation and Research responsible for the assessment of new drugs and therapeutic biologics. OND provides clinical, nonclinical, and regulatory expertise on the full range of drugs and therapeutic biologics that can be made available to the American people.

As the Deputy Super Office Director for Operations, the incumbent will oversee offices within OND that manage the regulatory, business process, and administrative operations, providing leadership and supervision on developing and implementing relevant processes and procedures, and assuring that key challenges that arise—related to staffing or regulatory or administrative operations are fully and efficiently addressed.  The role is responsible for evaluating the effectiveness of the various regulatory, business process, and administrative programs in OND and assuring that they are meeting established goals and objectives. OND is looking for a leader with a commitment to scientific excellence and innovative thinking to help lead a dynamic and diverse organization. The incumbent works closely with the Office of New Drugs Super Office Director and other OND Super Office Deputy Directors to formulate policies, set and implement operational strategies and priorities, and provide executive level leadership and direction in the execution of the organization’s regulatory, business process, and administrative operations.

Our ideal candidate will possess the following skills:

• Executive leadership experience with an established track record in leading organizations of significant size and complexity.
• Effective communicator who can drive collaboration, empower staff, and is committed to the Public Health mission.
• Demonstrate the ability and experience coordinating complex work and priorities and building coalitions with partners in other organizations.
• Ability to drive collaboration, empower staff, provide expert advice and consultation, coordinate program activities, and spearhead important program initiatives.
• Knowledge of leadership and organizational management principles and of operational management.
• Detailed understanding of drug development and a detailed understanding of US drug regulation.
• Ability to manage and lead a diverse interdisciplinary staff.

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

Graduate/higher level degree: degrees in Pharmacy (e.g., Pharm.D), in public health (e.g., MPH), or in a related medical or biological field (e.g., a master’s degree or Ph.D. in biological or medical sciences), or in organizational management (e.g., an MBA degree along with a bachelor’s degree, as described below).

Individuals with a bachelor’s degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position are also eligible with at least 10 years of experience in organizational leadership and management in a health care organization.

Degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the at the time the degree was obtained. Candidates must be U.S. citizens.

TO APPLY
Interested candidates may direct any questions concerning the position to: CDER-OND-Leadership-Employment@fda.hhs.gov. To apply, submit your cover letter and CV/resume to: CDER-OND-Leadership-Employment@fda.hhs.gov by September 19, 2024.

Please reference Job Reference ID: OND-DSOD-001 in the subject line of the email. 

ADDITIONAL INFORMATION

Please visit: https://www.fda.gov/about-fda/jobs-and-training-fda/title-21-job-opportunities

About FDA's Office of New Drugs

FDA is an agency within the Department of Health and Human Services. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Connections working at FDA's Office of New Drugs