VACANCY ANNOUNCEMENT

Announcement Number:

HHS-FDA-09-2004-0055

Position Title:

Supervisory Medical Officer

Series and Grade:

GS-0602-15

Full Performance Level:

GS-15

Opening-Closing Date:

09/27/2004 - 10/25/2004

Salary:

$100,231.00 TO $130,305.00

Hiring Agency:

Food and Drug Administration

Job Location(s):

1 vacancy in Rockville, MD

Remarks:

APPLICATIONS (RESUME AND APPLICATION QUESTIONS) MUST BE RECEIVED ON-LINE VIA THE HHS CAREERS WEB SITE BEFORE MIDNIGHT EASTERN STANDARD TIME ON THE CLOSING DATE OF THIS ANNOUNCEMENT. PLEASE SEE BELOW FOR DETAILS ON USING THE HHS CAREERS SYSTEM.

TRN Codes:

POC:

Rockville Center HelpDesk

Phone:

888-478-4340

E-mail:

quickquestions@psc.gov

Announcement Info:

Salary range listed above includes locality pay

AREA OF CONSIDERATION: 

Government-Wide - Who may Apply:  

Individuals who served or are currently serving under 
Career/Career-Conditional appointment in the competitive service.

Applicants covered under Interchange Agreements with Other Merit Systems.

Individuals who have reinstatement eligibility.

Individuals eligible under special appointing authorities whose status 
affords them non-competitive appointment.

Veterans who are preference eligibles or veterans who have been separated 
after 3 or more years of continuous active service performed under 
honorable conditions (VEOA).

POSITION DETAILS:

Appointment Type:  Permanent
Work Schedule:  Full Time 
Tenure:  Career/Career-Conditional 
Merit Promotion Position:  Yes		
Supervisory/Managerial:  Yes
Bargaining Unit:  No 
Travel Required:  Yes - Less than 20% Annually 
Relocation Expenses:  Will be Paid  		

Physicians may also be eligible for Physician Special Pay for total 
compensation up to $174,500 based on experience, qualifications, and 
medical specialty.

ORGANIZATIONAL LOCATION:

HHS, Food and Drug Administration (FDA), Center for Drug Evaluation and 
Research (CDER), Office of New Drugs, Rockville, MD

DUTIES AND RESPONSIBILITIES:

The Office of Oncology Products (OOP) is a newly formed organization within 
the Office of New Drugs (OND).  OOP will have overall responsibility for 
leadership and regulatory oversight of product development for cancer 
treatment and prevention, including drugs and biological products, as well 
as their evaluation for marketing approval.  The office will also have 
oversight responsibility of hematology and coagulation agents, radiation 
protection agents, as well as medical imaging and radiographic products 
used in the diagnosis, monitoring, and treatment of cancer and other 
diseases.

In addition to the responsibilities identified above, as Director, the 
incumbent will lead a cross-cutting FDA Oncology Program, including an 
Agency-wide Oncology Coordinating Committee to ensure proactive and 
coordinated policies and approaches to the development of products to treat 
and prevent cancer.  A critical aspect of the Director's responsibility 
will be to develop and maintain professional liaison with other government 
agencies regarding policies related to cancer (e.g., National Cancer 
Institute) and other professional and consumer stakeholders. 

Specific duties include: 

.  Establishing and coordinating policy and program objectives of the 
Office and its drug review Divisions.

.  Planning and developing overall activities, policies and procedures 
involving interpretation and adaptation of Center and Agency program and 
policy objectives.

.  Directing evaluations for safety and efficacy of investigational new 
drug applications, new biological products and supplemental new drug 
applications. 

.  Providing advice to pharmaceutical firms on the appropriate methods for 
drug study to help assure patient safety during clinical studies and 
studies after marketing. 

.  Making recommendations and decisions on approval or withdrawals of 
approval for new drug applications, biological license applications, 
investigational new drug applications, and marketed drugs in the U.S., as 
well as foreign drugs to be marketed in the U.S.

.  Providing consultation and advice on the evaluation of oncology products 
to the Office of the Commissioner, other FDA Centers, government 
organizations, foreign governments and international organizations.

.  Representing the Center and FDA on committees and at national and
international professional meetings.

.  Serving as part of the Senior Leadership Team in the Office of New Drugs 
(OND), working with the Director of OND to develop and implement 
scientific, medical and regulatory policy as it applies to the review and 
oversight of drug development, review and approval.

.  Implementing quality systems and management initiatives established by 
the Director of OND.

BASIC QUALIFICATIONS:

Degree: Doctor of Medicine or Doctor of Osteopathy from a school in the 
United States or Canada approved by a recognized accrediting body in the 
year of the applicant's graduation. [A Doctor of Medicine or equivalent 
degree from a foreign medical school that provided education and medical 
knowledge substantially equivalent to accredited schools in the United 
States may be demonstrated by permanent certification by the Educational 
Commission for Foreign Medical Graduates (ECFMG) (or a fifth pathway 
certificate for Americans who completed premedical education in the United 
States and graduate education in a foreign country).]

AND

Graduate Training: Subsequent to obtaining a Doctor of Medicine or Doctor 
of Osteopathy degree, a candidate must have had at least 1 year of 
supervised experience providing direct service in a clinical setting, i.e., 
a 1-year internship or the first year of a residency program in an 
institution accredited for such training. (This 1 year of supervised 
experience may be waived for research or administrative positions not 
requiring direct patient care.) For purposes of this standard, graduate 
training programs include only those internship, residency, and fellowship 
programs that are approved by accrediting bodies recognized within the 
United States or Canada. Listings of accredited programs are published 
yearly in the Directory of Residency Training Programs and the Yearbook and 
Directory of Osteopathic Physicians. 

.  An internship program involves broadly based clinical practice in which 
physicians acquire experience in treating a variety of medical problems 
under supervision (e.g., internal medicine, surgery, general practice, 
obstetrics-gynecology, and pediatrics). Such programs are in hospitals or 
other institutions accredited for internship training by a recognized body 
of the American Osteopathic Association (AOA). 

.  A residency program involves training in a specialized field of medicine 
in an institution accredited for training in the specialty by a recognized 
body of the American Medical Association (AMA) or AOA. 

.  A fellowship program involves advanced training (beyond residency 
training) in a given medical specialty in either a clinical or research 
setting in a hospital or other institution accredited in the United States 
for such training. 

AND

5 years of residency training in the specialty of the position to be filled 
or equivalent experience and training.  Specifically, experience in 
oncology drug or biological product development, clinical trial design and 
analysis.

We must receive proof of your Medical Degree and Internship, 
Residency and/or Fellowship within 72 hours of the closing date of this 
vacancy in order for you to be considered.  If you are currently, or have 
previously been, an 0602 in the Federal Government an SF-50 showing your 
series and grade will be sufficient.  Please fax your documentation to the 
attention of the Rockville HR Center HelpDesk at 1-888-839-5244.  Please 
include the vacancy announcement number on all documentation 
submitted.

YOU MUST MEET ALL QUALIFICATION REQUIREMENTS WITHIN 30 DAYS OF THE CLOSING 
DATE.  THIS INCLUDES TIME IN GRADE REQUIREMENTS FOR CURRENT STATUS 
EMPLOYEES.

CONDITIONS OF EMPLOYMENT:  

Certain positions within the FDA are subject to strict restrictions on 
financial holdings (FDA regulated financial holdings).  To determine 
whether this position is affected, applicants are advised to seek 
additional information during the interview process from the Ethics and 
Integrity Staff, Office of Management Programs, Office of Management at 
(301) 827-5511 prior to accepting such a position.

QUESTIONS REGARDING THIS ANNOUNCEMENT SHOULD BE REFERRED TO:
 
Rockville Center HelpDesk
Telephone (888)-478-4340
quickquestions@psc.gov
Hours of operation: Monday through Friday 7:30AM to 4:00PM EST
TTY/TDD (800)-877-8339

HOW TO APPLY: 

Applications (resume and application questions) for this vacancy MUST be 
received on-line via the HHS Careers QuickHire web site before midnight 
Eastern Standard Time (click here for current time) on the closing date of 
this announcement.
 
The HHS Careers QuickHire system simplifies the Federal application 
process by replacing the former KSA job-element statements with on-line 
self-assessment questions.  Your resume and responses to the 
self-assessment questions are an integral part of the process for 
determining your basic and specialized qualifications for the position.  
Therefore, it is important to support your responses to the applicant 
assessment questions by providing examples of past and present experience 
when requested.

There are several parts of the application process that affect the overall 
evaluation of your application:

1.	Your resume
2.	Your responses to the core questions
3.	Your responses to the self-assessment questions
4.	Your supporting documents

High self-assessment in the vacancy questions that is not supported by 
information in your resume, essay responses, and/or supporting documents 
may eliminate you from best-qualified status or result in a lowered score. 

Additional details on the application process can be found at the end of 
this announcement.

The HHS QuickHire web site can be accessed at: 
https://jobs.quickhire.com/scripts/hhs.exe

SUPPORTING DOCUMENTATION:

Supporting documentation (Standard form 50, DD-214, etc.) MUST be 
received no later than 72 hours from the closing date of this announcement.  
Documentation must be faxed to the attention of the Rockville Center 
HelpDesk at 1-888-839-5244.  Include the vacancy announcement number on all 
faxed documents.  Do not fax resumes or applications. Failure to submit 
documents within the required timeframe WILL eliminate you from 
consideration for this position.

REASONABLE ACCOMMODATION:

This agency provides reasonable accommodation to applicants with 
disabilities. If you need a reasonable accommodation for any part of the 
application and hiring process, please contact the Rockville Center 
HelpDesk Telephone (888)-478-4340, TTY/TDD (800)-877-8339; email 
quickquestions@psc.gov.The decision on granting reasonable accommodation 
will be made on a case-by-case basis.

If applying online poses a hardship to you, the Rockville Center HelpDesk 
listed on the announcement will provide assistance to ensure that 
applications are submitted online by the closing date.  You must contact 
the Rockville Center HelpDesk prior to the closing date of this 
announcement to receive assistance.  Hours of operation: Monday through 
Friday 7:30AM to 4:00PM EST

ADDITIONAL DETAILS ON USING THE HHS CAREERS QUICKHIRE SYSTEM


1. If you have never used the HHS Careers QuickHire system you will need to 
register as a new user.  Registration will involve entering your resume 
into the system and responding to a series of core questions that will 
allow the HHS HR specialists to evaluate your background for basic 
employment eligibility.  

2. Once you have completed the registration process you must locate and 
view the vacancy you wish to apply for on the HHS Careers QuickHire system.  
Scroll down to the end of the vacancy announcement and select the "Apply to 
this Vacancy" button.  Answer ALL questions that follow.  You must click 
"Finished" button at the bottom of the screen to be considered for a 
specific position.  Upon completing the application process you will 
receive an electronic acknowledgement that you application has been 
successfully transmitted.  Select the "I would like a copy of the questions 
and my responses sent to my e-mail account." option to have your responses 
emailed to you.

NOTE: We encourage you to select the "View Vacancy Questions" button so you 
may preview the vacancy questions prior to applying for this position.  


You will not be considered for the position if any part of the application 
is incomplete. You must provide the required user information (including 
your resume in the designated section), as well as responses to the 
questions specific to the vacancy in order to receive consideration.

ADDITIONAL EMPLOYMENT INFORMATION:
Veterans Information

Former Federal employee reinstatement eligibility

Department of Health and Human Services (DHHS) Surplus or displaced 
Employees CTAP criteria.

Displaced Federal employees ICTAP criteria.