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-MP-10080304JJ under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion 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-MP-10080304JJ under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion 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 segment(s), 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 Requirement: You must be a U.S. Citizen to be considered for this advertisement.
Selective Servie Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.
FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepency arises, you must take affirmative steps to resolve the problem.
Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be have a background check at a later time.
Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.
You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered.
Qualifications
In order to qualify for the Supervisory Interdisciplinary Scientist GS 0401/0405-15 , you must meet all requirements listed below 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.
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.
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
ADDITIONAL CONDITIONS OF EMPLOYMENT:
If you are serving, or have served in the last 5 years (from 03/01/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. 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 Appointee FAQ - OPM
Incentives may be authorized; however, this is contingent upon funds availability.
Pre-Employment Physical: NO
Drug Testing Requirement: NO
License Requirement: NO
Immunization Requirement: NO
Mobility Agreement Required: NO
Bargaining Unit Position: NO
Veteran's Preference: If you plan to apply for any time of Veterans 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.
Financial disclosure statement, OGE-450, required: Please be advised that this position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers..
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How you will be evaluated
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), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position.
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: Category rating procedures 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 assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
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
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
"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
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.
ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:
Veterans: 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. 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 Applicant Help Desk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10081017.) Decisions on granting reasonable accommodation will be made on a case-by-case basis. The Applicant Help Desk is staffed from the hours of 7am to 6pm Eastern Time.
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 (03/01/2018). You will receive 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.
"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
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.
ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:
Veterans: 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. 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 Applicant Help Desk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10081017.) Decisions on granting reasonable accommodation will be made on a case-by-case basis. The Applicant Help Desk is staffed from the hours of 7am to 6pm Eastern Time.
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 (03/01/2018). You will receive 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.