• 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.
• 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 Division Director in the absence of the Division Director, for all areas of responsibility assigned to the Division Director.

Conditions of employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.
• Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
• Selective Service 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 discrepancy 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 subject to 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 time-in-grade qualifications attained by this date will be considered.
• You may be required to serve a one year supervisory probationary period.

Qualifications

In order to qualify for Supervisory Interdisciplinary Scientist, 0401/0405, at GS - 15, you must meet Time-in-Grade requirements by 04/12/2018.

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 bachelor's degree or higher degree at an accredited college or university 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 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.

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.

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 04/12/2018), 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 this internal position. Eligible internal candidates will be referred to the hiring official for consideration.

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. To review the application questionnaire, click the link below.

• Program Management

• Advisory Assistant

• Administrative and Budgetary Knowledge

• Supervision and Leadership

• Communications

• https://apply.usastaffing.gov/ViewQuestionnaire/10165681