Jobs at the Center for Drug Evaluation and Research (CDER)

You Can Make a Difference

At the Center for Drug Evaluation and Research (CDER), you can make a difference in protecting the health of the American people. We have an ongoing need for qualified individuals with backgrounds in health-related sciences, health policy, and information technology. Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. Join HHS and help to make our world healthier, safer and better for all Americans.

• Mission and Activities of CDER

• Careers at CDER  

• Salary

• Benefits 

• FDA Financial Disclosure and Conflict of Interest Information

Mission and Activities of CDER

The mission of the FDA's, Center for Drug Evaluation and Research (CDER) is to assure that safe and effective drugs are available to the American people. CDER promotes, protects, and enhances the health of the public through the drug development and evaluation process which:

• Approves drugs for marketing that are effective, have had their adverse effects adequately studied, provide benefits that outweigh their risks, and are of high quality and have directions for use that are complete and honestly communicated.
• Evaluates marketing applications in a timely fashion, with special priority to drugs for serious illness, especially if there is no adequate therapy. CDER shares with the regulated industry, scientific groups, and the public, the goal of identifying promising new drugs and developing them expeditiously.
• Facilitates early access to promising drugs being developed for serious illnesses with no adequate therapy.
• Promotes innovations and provides scientific leadership in the drug development process through collaborative work with the industry, academia and domestic foreign agencies and organizations.
• Assures that the safety and rights of patients in drug studies are adequately protected.
• Assures that product quality and safety are maintained after marketing and that new information about drugs is actively sought, evaluated, and communicated in a timely fashion.

To learn more about the FDA, CDER, and new drug development, please use these links.

• FDA Home Page

• About the FDA

• CDER Home Page

• New Drug Development in the United States
  

• Physicians. (Various medical specialties)  Evaluate data involving the animal testing and human clinical trials of new drugs to determine their safety and effectiveness. Basic qualification is a Doctor of Medicine or Doctor of Osteopathy. Graduates of foreign medical schools must be ECFMG certified. Board certification/eligibility in a medical specialty and experience in conducting clinical trials are highly desired for these positions. Physicians may also be paid an additional Physician Comparability Allowance up to $24,000 (depending on years of Federal experience). GS14-10-GS15-10.  Advanced search terms at USAJOBS include: CDER (keyword), 0602 (series), medical officer (occupational series), FDA (agency).
   
• Reviewers. Reviewers evaluate data submitted by sponsors of an Investigational New Drug Application and New Drug Applications to support the marketing of a drug. A typical pre-market (prior to FDA approval of a drug) review team consists of the following disciplines:
  • Medical Officer/Physician (see description above)
  • Project Manager/Consumer Safety Officer (see description below)
  • Chemist
  • Toxicologist
  • Statistician
  • Clinical Pharmacologist

  A typical post-market review team consists of the following disciplines:

  • Epidemiologist
  • Risk Management specialist
  • Safety evaluator

  These roles can be filled by individuals with varying backgrounds, including but not limited to Biologists, Chemists, Microbiologists, Pharmacologists, Pharmacokineticists, Toxicologists, Epidemiologists, Nurses, and Pharmacists, among others. These reviewers evaluate portions of INDs/NDAs that pertain to their particular discipline. They determine the scientific validity of manufacturers’ tests, drug safety and efficacy claims. A doctorate degree in a relevant scientific discipline with at least two years post-doctorate experience is highly desired, but not required for these positions. GS12-GS13.

• Consumer Safety Officers (Regulatory Health Project Managers).  Perform management and liaison responsibilities throughout the lifecycle of a product. In addition, they serve as the regulatory expert on the review team, advise team members on regulatory requirements, and coordinate information with pharmaceutical industry officials. Qualifications: a degree or combination of courses in the fields of biological science, chemistry, pharmacy, nursing, physical science, food technology, nutrition, medical science, epidemiology, engineering, veterinary medical science, or related scientific fields. Project management experience in the health care/pharmaceutical industries is highly desired for these positions. GS5-GS13. Advanced search terms at USAJOBS include: consumer safety (keyword), 0696 (series), FDA (agency).
• Mathematical Statisticians. Provide statistical support to the drug review divisions. Employ a broad variety of statistical procedures relevant to the regulatory and scientific preclinical and clinical drug development and approval decision processes. A doctorate degree in mathematics/statistics and experience in the design, performance and evaluation of clinical trials or related biomedical or pharmacokinetics investigations are highly desired for these positions. GS11-GS13
• Regulatory Counsel. Work with scientific, medical, and legal staff to develop, interpret, and implement statutes, regulations, policies, and procedures pertaining to the regulation of human drugs. Regulatory counsels work in various offices throughout the Center including the Office of Regulatory Policy (doing policy or disclosure work), the Office of Compliance, and the Division of Drug Marketing, Advertising, and Communications. Regulatory counsels typically have legal training and prior legal/regulatory experience. GS11-GS15
• Computer Specialists.  Provide ADP infrastructure, application and technology services to CDER in support of automated drug review, administrative, data storage/retrieval and training processes. The following education or experience is highly desired for these positions: an undergraduate/graduate degree in computer science, information science, information systems management, mathematics, statistics, operations research, engineering, or course work that required the development and/or adaptation of computer programs and systems and provided knowledge equivalent to a major in the computer sciences, or experience that demonstrated accomplishment of computer project assignments that required a wide range of knowledge and techniques pertinent to the position to be filled, such as experience in software development tools (Oracle Developer 2000, Oracle Designer 2000 and Java), server (DEC Alpha, WIN/NT, MS Windows), and web development tools. GS9-GS13
• Administrative Support Personnel. Perform program support work for various programs of the agency. Provides support work such as administrative document review and analysis, and assisting with quality assurance and regulatory status of submissions. Assist in the implementation, coordination, management, and completion of special projects or individual assignments as directed. Develops budget, financial, travel, and training plans, oversees procurement and property matters, develops space plans and requests, recommends personnel actions based on analysis of situations reflecting the best interests of employees and advancement of programs. Directs execution of financial plan to facilitate necessary supplies, equipment, repairs, support services, travel, and training necessary to optimize utilization of available resources. GS5-GS13. Advanced search terms at USAJOBS include: CDER (keyword), 0301 (series), administration & program staff (occupational series), FDA (agency).
• Leadership Positions. There are various leadership positions available in almost every category described above in CDER. Most, but not all, require at least a Master’s Degree or higher depending on the discipline necessary for the position. An employee in a leadership position is expected to provide direction, oversight and a forward vision for his particular discipline, and may serve as a Team Leader, Supervisor or Director. GS14-15.
• Staff Fellow. Permanent U.S. residents can apply for Staff Fellowship appointments as physicians, scientists, or mathematical statisticians. Graduates of foreign college or universities must provide proof of U.S. education equivalency certification. Staff Fellowships provide opportunities for promising research/regulatory review scientists to advance and enhance their careers through close associations with leading authorities in health-related research. Fellowships also serve to strengthen the research community by facilitating the exchange of talent between the Agency and other research centers. Initial Staff Fellow appointments will be made for up to four years with extensions made on a year-to-year basis or conversion to permanent status, once U.S. citizenship is obtained.
• Commissioner's Fellowship. The FDA offers a two-year Commissioner's Fellowship Program, which provides an opportunity for health professionals and scientists to receive training and experience at the FDA. Salaries are extremely competitive, and travel funds are available to attend scientific meetings. The Commissioner's Fellowship Program offers Fellows rigorous coursework and the opportunity to develop and pursue a regulatory science research project. Under the guidance of an FDA senior scientist Preceptor committed to mentoring, Fellows will explore specific aspects of FDA regulatory science. Applicants must generally have a Doctoral level degree (M.D., D.O., D.V.M., D.D.S., D.P.M., Pharm.D., or Ph.D.) to be eligible, although applicants with a Bachelor's degree in an engineering discipline will also be considered. Applicants must be U.S. citizens, non-citizen nationals of the U.S., or have been admitted to the U.S. for permanent residence before the program start date. Current FDA employees or FDA contractors (such as ORISE fellows) may not apply.

Salary

• Appointments under this authority may only be used to fill scientific supervisory/managerial positions.
• Individuals appointed under this authority must possess a high level of critical scientific/professional qualifications and expertise. Nominees must have: -evidence of recognition as a national or international expert in the field, such as invited manuscripts, presentations, and consultations; receipt of honors and awards; or other recognition for noteworthy performance or contributions to their scientific field -evidence of original scientific or scholarly contributions of major significance in their field -evidence of leadership in the field equivalent to a full tenured professor in academia. And -special knowledge and skills of benefit to FDA.
• All appointments are in the excepted service and are made without regard to civil service laws. Title 5 civil service rules and regulations do not apply under Title 42—for example, performance related personnel actions, classification, general schedule pay rates and retention preference.
• Applicants must meet positive education requirements for the type of scientific position being filled. All foreign education must be accredited by a national or regional accrediting association in the United States.
• Salary range starts at GS-15 step 1 ($123,758) not to exceed - $250,000.

  Senior Biomedical Research Service

• The SBRS is a personnel system employed by the Food and Drug Administration and other health and science agencies within the Department of Health and Human Services to enable these agencies to recruit and retain senior scientists in the areas of biomedical research and clinical/product research evaluation.
• At the Food and Drug Administration, SBRS members perform biomedical research and/or perform work related to the evaluation of the safety and effectiveness of human and animal drugs and devices, biological products, blood, blood products and vaccines; the safety of food, cosmetics, food and color additives; and radiation emitting products and devices. SBRS physicians, dentists, veterinarians and scientists may be employed in any of the research or review activities of the FDA.
• Senior scientists who have earned a doctoral level degree and who meet the GS-15 level qualification requirements, possess the training and experience needed for specific positions within the Food and Drug Administration and whose credentials are certified by a rigorous peer review process are eligible for SBRS appointment.
• The SBRS is an upgraded personnel system. Appointments are in the excepted service. Salaries range from the first step of the GS-15 grade level through Executive Level I.
• Salary range starts at GS-15 step 1 ($123,758) not to exceed Executive 1($199,700).
  

  Senior Executive Service

• The Senior Executive Service (SES) is a separate personnel system in the executive branch for career and non-career employees who serve in the key positions just below the top Presidential appointees. SES members are the major link between these appointees and the rest of the Federal workforce to ensure that the executive management of the government is responsive to the needs, policies and goals of the nation.
• The SES includes most managerial, supervisory, and policy determining positions classified above GS 15 or equivalent positions in the Executive Branch of the Federal Government.
• Must possess experience, education and/or potential relating to the following executive core qualifications: leading change, leading people, results driven, business acumen, and building coalitions. Applicants also must meet the minimum educational requirements for the occupational series of the position.
• Salary Range not to exceed $179,700.
  
  Title 38 Physicians and Dentist Pay (PDP)
  
• Physician and Dentist Pay (PDP) is a hybrid pay authority intended to recruit and retain highly qualified physicians and dentists at a GS-15 and below by providing a mechanism to compensate them at levels comparable to private sector physicians and dentists within the same locality area.
• T38 pay authority establishes a 2-component system of pay for HHS physicians and dentists consisting of Title 5 General Schedule (GS) base pay and Title 38 market pay.
• Physicians and dentist selected to participate under this developmental program will be hired on an excepted appointment under Schedule A, 213.3102(r) and will be paid using the Title 38 pay model. Appointments under this authority may not exceed 4 years. However, physicians and dentists who successfully complete this program may be considered for a competitive service appointment.
• Physicians and dentists hired under Title 42 authorities, for example, fellowships, Senior Biomedical Research Service (SBRS), are not eligible to receive market pay under Title 38.

Salary range starts at General Schedule pay table GS-14 step 1.
 

Benefits 

• Annual Leave.  The Federal Government authorizes absence from work, usually through earned leave for its employees. Annual leave (similar to vacation leave) is earned on the basis of years of Federal service. Full-time employees with less than three years of service earn 13 days of annual leave a year. Full-time employees with at least three but less than fifteen years of service earn 20 days of annual leave a year; and full-time employees with fifteen or more years of service earn 26 days of annual leave a year. You can carry over up to 240 hours from one year to the next. Anything over that amount will be lost if it is not used by the end of the calendar year.
• Sick Leave.  Employees earn a total of 13 days of sick leave a year, regardless of length of service. There is no limit on the amount of sick leave which may be accumulated and carried over from year-to-year.
• Other Leave.  Provisions are made to accommodate absences for reasons such as maternity, religious, military obligations, court attendances, etc.
• Holidays.  Government workers receive paid time off for 10 holidays; in addition to earned annual leave.
• Health Insurance.  The Federal Employees Health Benefits Program is a voluntary contributory program open to almost all employees depending on the type of appointment. There are over 100 health insurance carriers participating in the program. Through these various plans employees are offered an opportunity to acquire for themselves and their families protection against the cost of health care services, including those involved in prolonged illnesses or serious accidents. The Government contributes to the cost of the plans with employee paying their share through payroll deduction.
• Life Insurance.  Most Federal civilian employees are eligible to select low-cost life insurance provided through the Federal Employees Group Life Insurance Program. Participation is entirely voluntary and the cost of coverage is based on the employee’s salary. The Government contributes to the cost of the plans with employees paying their share through payroll deductions.
• Retirement.  New employees will be covered by the Federal Employees Retirement System (FERS). The FERS is a three-tiered retirement system comprised of payments from Social Security, and Basic Annuity Plan, and a tax-deferred thrift savings plan. Under the thrift plan, employees may elect to contribute any dollar amount of percentage (1-100) of their basic pay. However, the annual dollar total cannot exceed the Internal Revenue Code limit. This amount changes annually - for 2010, the limit is $16,500.00. These savings can be invested in up to ten different investment funds with interest earned.
• Please visit www.opm.gov for information regarding benefits.

FDA Financial Disclosure and Conflict of Interest Information 

• FDA employees are subject to certain ethical standards. Below is a summary of limitations on financial holdings as well as restrictions on concurrent and future employment and links to additional information.
   

  Financial Disclosure  FDA’s regulations prohibit certain employees from holding a financial interest in a significantly regulated company. "Significantly" means that more than 10% of the firms products or income are derived from products or services regulated by FDA. Examples of prohibited financial interests include stock holdings, in pharmaceutical, medical device firms, and major food producers.

• Federal Conflict of Interest Statutes 
  The Federal conflict of interest statutes assure that Government employees conduct Government business effectively, objectively, and without improper influence. These statutes govern representational activities, financial interests, outside compensation, and use of official information by Government employees.
• CDER Manual of Policy and Procedures: Outside Activities 
  FDA Conflict of Interest Regulations require advance administrative approval prior to an employee participating in certain outside activities, whether paid or unpaid.
• FDA Ethics Program -- Post Employment Restrictions 
  FDA employees are subject to certain restrictions after they leave Federal service.

For further information on acceptable industries those industries which are significantly regulated, please visit Listing of US Industries.

FDA is an equal opportunity employer with a smoke free environment.