This position is located in the Department of Health and Human Services, Food and Drug Administration, Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Division of Pharmacometrics, located in Silver Spring, MD.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-DE-10081017JJ under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. Applicants must apply separately for each announcement in order to be considered under both. Additional selections may be made within the same geographical area FDA-wide.
Summary
This position is located in the Department of Health and Human Services, Food and Drug Administration, Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Division of Pharmacometrics, located in Silver Spring, MD.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-DE-10081017JJ under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. Applicants must apply separately for each announcement in order to be considered under both. Additional selections may be made within the same geographical area FDA-wide.
This position will serve as the Deputy Director and will have the following responsibilities:
Plan, manage, organize, and direct all regulatory review operations, program segments, functions, and activities of the Division as carried out by subordinate team leaders and a staff (scientific, engineering, medical, statistical, science, and/or veterinary medical officer) of professionals organized into either formal or informal subordinate organizations responsible for the regulatory review mission of the Division.
Ensure that reviewers provide quality review and consultation to customers within established timeframes for the science and administration functions of the Division
Evaluate budget, fiscal, and administrative controls to manage Division program segments and services.
Play a key leadership role in critical industry meetings, identifies issues related to pharmacometrics and collaborates with other disciplines to ensure that key questions and drug development issues are addressed.
Lead the preparation, clearance, and finalization of Division responses to inquiries covering all aspects of the programs, functions, and activities of the Division.
Provide oversight of the development of CDER's model-informed drug development initiatives, including services and operations in support of regulatory activities.
Serve as a full deputy to the Director in the absence of the Director, for all areas of responsibility assigned to the Director.
Citizenship: U.S. Citizenship is required for Federal employment.
Probationary Period: A one year probationary period is required for first time Supervisors.
Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
Pre-employment physical required: No
Drug testing required: No
License required: No
Mobility agreement required: No
Immunization required: No
Bargaining Unit Position: No
Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
Qualifications
In order to qualify for the Supervisory Interdisciplinary Scientist GS 0401/0405-15 , you must meet Time-in-Grade requirements by 03/01/2018
Basic Requirement Biologist, GS- 0401;
Must possess a degree in biological sciences, agriculture, natural resource management, chemistry, or a related discipline. (You must submit transcript at time of application submission) OR
Must possess coursework equivalent to a major as shown in A above plus additional education or appropriate experience. (You must submit transcript at time of application submission).
Basic Requirement Pharmacologist, GS- 0405;
Must have successfully completed a full four-year of study at an accredited college or university leading to a bachelor's or higher degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology. (You must submit transcript at time of application submission)
In addition to meeting the Basic Requirements listed above you must also meet the following:
Minimum Qualifications GS-0401/0405-15;
Must have one year specialized experience, equivalent in complexity and difficult to at least the GS-14 grade level in the Federal Service that include leading program operations of drug products and quality during the lifecycle of both brand and generic products; developing policy and providing scientific evaluation of processes and facilities for new drug and generic drugs; evaluating program performance and developing actions to ensure attainment of program goals; and managing or directing staff.
In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
Who May Apply (in detail):
Federal employees with career or career-conditional appointments in the competitive service;
Former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments;
Displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) or the Interagency Career Transition Assistance Program (ICTAP);
Veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service;
Military Spouses;
PHS Commissioned Corps Officers;
Individuals eligible for VRA appointments (at the GS-11 and below grade levels);
Individuals with disabilities who quality for a Schedule A appointment.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.
Education
You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
Additional information
If you are serving, or have served in the last 5 years (from 03/01/2018 You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire Political Appointees FAQ-OPM.
Veteran's Preference: If you plan to apply for any kind of Veteran Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.
Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Disability Employment
Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Workforce Restructuring
Requirements continued: Financial disclosure statement, OGE-450, required: Yes
Please be advised that this position will be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
All qualification requirements (including time-in-grade) must be met by 11:59 pm (Eastern Time) on the closing date of this announcement ( ).
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm ET on 03/01/2018 If,after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified. Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
The following documents are ACCEPTED for this vacancy:
Cover Letter
DD-214
ICTAP/CTAP/Schedule A letter/Commison Corp Documentations
VA Letter
Resume
SF-15
SF-50
Transcript
"Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.
The following documents are REQUIRED for this vacancy:
Resume and Transcript "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.
STATUS CANDIDATES - REQUIRED DOCUMENT DETAILS
Current and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility!
Full position title;
appointment type;
occupational series;
pay plan, grade, and step;
tenure code; and
service computation date (SCD).
If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.
Veterans: You will need to submit appropriate veteran eligibility documentation (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.
Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM Guide to Career Transition for more information.
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
To apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section below. To receive consideration for this position you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement (03/01/2018)
Instructions for applying to this job:
You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can apply
If you are signed in, you can tap/click "Apply Online" to begin the process.
USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS Resume Help site.
USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.
You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).
Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.
Instructions for reviewing or editing your application:
If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".
You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.
You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.
You are encouraged to apply online. Applying online will allow you to review and track the status of your application.
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 Bethesda Customer Help Desk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (In your e-mail request, please replace the blank line with the Vacancy Identification Number, VIN, for this job, which is:10080304. Decisions for granting a reasonable accommodation will be made on a case-by-case basis.
FDA Center for Drug Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement. You will application status updates via email and via USAJOBS as the process unfolds.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
The following documents are ACCEPTED for this vacancy:
Cover Letter
DD-214
ICTAP/CTAP/Schedule A letter/Commison Corp Documentations
VA Letter
Resume
SF-15
SF-50
Transcript
"Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.
The following documents are REQUIRED for this vacancy:
Resume and Transcript "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.
STATUS CANDIDATES - REQUIRED DOCUMENT DETAILS
Current and former Federal employees: You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility!
Full position title;
appointment type;
occupational series;
pay plan, grade, and step;
tenure code; and
service computation date (SCD).
If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.
Veterans: You will need to submit appropriate veteran eligibility documentation (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.
Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the OPM Guide to Career Transition for more information.
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
To apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section below. To receive consideration for this position you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement (03/01/2018)
Instructions for applying to this job:
You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can apply
If you are signed in, you can tap/click "Apply Online" to begin the process.
USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS Resume Help site.
USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.
You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).
Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.
Instructions for reviewing or editing your application:
If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".
You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.
You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.
You are encouraged to apply online. Applying online will allow you to review and track the status of your application.
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 Bethesda Customer Help Desk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (In your e-mail request, please replace the blank line with the Vacancy Identification Number, VIN, for this job, which is:10080304. Decisions for granting a reasonable accommodation will be made on a case-by-case basis.
FDA Center for Drug Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement. You will application status updates via email and via USAJOBS as the process unfolds.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
