Clinical Pharmacists - Pharmacotherapy - Oncology - Investigational Drug Control Unit (IDCU)

Montgomery County, Maryland
Jan 07, 2021
Jan 14, 2021
Full Time


The NIH Clinical Center Pharmacy is seeking exceptionally talented, knowledgeable, and motivated Clinical Pharmacists in the following specialties/backgrounds:

Total number of vacancies: 3
    Pharmacist (Clinical) - Oncology Pharmacist (Clinical) - Pharmacotherapy Pharmacist (Clinical) - Investigational Drug Control Unit (IDCU)
All Clinical Pharmacists must demonstrate a mastery of providing patient care and understand research methodologies, protocol design, and implementation.
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The NIH Clinical Center Pharmacy Department is seeking Clinical Pharmacists in the following specialties:

The successful candidate will be an exceptionally talented, knowledgeable, and motivated Clinical Pharmacist with extensive experience providing pharmaceutical care to adult cancer patients. The Clinical Pharmacist must demonstrate a mastery of providing patient care and understand research methodologies, protocol design, and implementation. A Doctor of Pharmacy degree, post-graduate year 1 and year 2 residency training, board certification (BCOP), and 3 to 5 years of patient care experience are highly desired for this position.

Pharmacotherapy Specialist
The successful candidate will be an exceptionally talented, knowledgeable, and motivated Clinical Pharmacist with extensive experience providing pharmaceutical care to inpatients and outpatients with a variety of diseases especially diabetes, musculoskeletal disorders, cardiovascular and hematologic diseases, and neurologic conditions. The Clinical Pharmacist must demonstrate a mastery of providing patient care and understand research methodologies, protocol design, and implementation. A Doctor of Pharmacy degree, post-graduate year 1 and year 2 residency training, board certification, and 3 to 5 years of patient care experience are highly desired for this position.

Investigational Drug Control Unit Specialist
The successful candidate will be an exceptionally talented, knowledgeable, and motivated Clinical Pharmacist with extensive experience supporting clinical trials with protocol development and consultation, protocol review and pharmacy procedure set-up and implementation, investigational drug information, inventory management, record keeping, and quality assurance; knowledge of applicable laws and regulations that regulate clinical trials including FDA requirements, ICH GCP guidelines, Joint Commissions, USP and pharmacy laws. All Clinical Pharmacist must demonstrate a mastery of providing patient care and understand investigational drug handling and management methodologies, protocol design, and implementation.

As a Clinical Pharmacist with the NIH Clinical Center's Pharmacy Department, your duties will include but are not limited to the following:
  • Independently advises, interfaces and participates with physicians in the design of complex drug treatment plans; monitors and evaluates drug therapy for beneficial therapeutic outcome;
  • Designs drug regimens utilizing current pharmacokinetic and pharmacodynamic principles and specific patient parameters; supports and implements clinical research studies
  • Recommends modifications when changing organ system's functions dictate need; participates in daily rounds monitor and review drug therapy for rational indications, dosing, adverse drug reactions, drug interactions; IV incompatibilities and complications of multiple drug therapies;
  • Advises physician on drug selection when appropriate and conduct pharmacy rounds daily to assess pharmaceutical care needs of patients including assessment of favorable therapeutic outcome;
  • Monitors and detects adverse drug reactions, completes all necessary reports; reports all significant findings to in-house committees and FDA;
  • Serves as expert consultant to in-house committees for selection and evaluation of drugs for formulary listing;
  • Proactively brings new pharmacotherapy advances in own specialty area to in-house committees and makes recommendations for inclusion in the formulary;
  • Serves as a technical authority and resource with direct interaction with patients to independently obtain complete drug histories, including over-the-counter medications and alternative drug therapies and integrates information into treatment plan.
  • Serves as primary pharmacy contact to support intramural clinical trials with protocol review and pharmacy procedure set-up
  • Manage investigational drug inventories throughout the entire life cycle of the study.
  • Provide advice to investigators, study team members, and pharmacy staff on the complexities related to implementing protocols with investigational drugs, in compliance with FDA requirements, ICH, GCP guidelines, Joint Commissions, NIH CC, and Pharmacy policies and SOPs.

Travel Required

Not required

Supervisory status

Promotion Potential


Conditions of Employment

  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • License Required. Recommend including a copy of your current active Pharmacist License with your application.
  • Position(s) requires education. Recommend including a copy of your transcripts with your application.
  • Physical Requirement: Work is performed in a clinical environment and requires physical exertion to include lifting and carrying light objects and sitting, walking, or standing for long periods of time (i.e., 4-8 hours).
  • In addition, work may also require specific physical characteristics to include dexterity to perform fine precise work, delicate adjustments, and exact measurements associated with investigational and specialized drugs.
  • Safety and Health Requirements: Incumbent is expected to comply with all aseptic techniques, influenza vaccination, safety regulations and Clinical Center policies and procedures.
  • Work may also expose incumbent to infectious diseases (e.g., tuberculosis) and investigational drug therapy for which very little information is known.
  • You must be able to pass a pre-employment medical examination, and may be required to provide proof of Influenza vaccination.


You qualify at the GS -0660-13 level, if you meet the following qualification requirements:

Basic Qualification Requirements:


A doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (ACPE) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.


Applicants who have a bachelor's degree in pharmacy may also qualify contingent upon an additional review of your qualifications.

All applicants must have passed the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE).All applicants must be licensed to practice pharmacy in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.

Specialized Experience:
In addition to meeting the basic requirements, the following amount of specialized experience is required to qualify for positions at GS-13. You must demonstrate in your resume at least one year of qualifying experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing inpatient and outpatient pharmacy dispensing services including the preparation of sterile products; preventing drug reactions or interactions; performing ongoing clinical pharmacy monitoring for patients participating in clinical trials, including therapeutic drug monitoring and dose adjustments based on organ function, while ensuring protocol compliance; providing research support and investigational drug management for clinical trials involving adult and pediatric research subjects; developing policies, procedures and informational material for investigational drug management; monitoring and auditing clinical trials for adherence to federal regulation.

Preview assessment questionnaire before you apply:


This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education .

Additional information

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .
  • These positions are designated as an " emergency essential " position and the selected candidate will be considered an " emergency essential " employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage.
  • At the supervisor's discretion, these positions may offer telework as a work schedule flexibility.
  • Financial disclosure is limited to the Clinical Pharmacist (Pharmacotherapy) position where the incumbent is selected to serve on scientific review committees and/or Institutional Review Boards (IRB). If selected, you may be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: .
  • A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
  • A one-year probationary period may be required upon selection/placement.
  • PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration.
  • The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program ( E-Verify ). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
  • The NIH maintains a tobacco free work environment and campus.
  • Must be able to perform the essential duties of the position, with or without reasonable accommodation.
  • Visit our Applicant FAQs page for helpful information on the application process.
  • Visit our Total Compensation page for a detailed look into the benefits, awards, leave, retirement and other incentives employees may receive as part of a rewarding work environment.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.

The position(s) advertised in this announcement are covered by a direct hire authority. Traditional rating and ranking of applicants, including category rating, does not apply to this vacancy. You will be initially evaluated against the basic qualifications only. Qualified applicants will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines . Veterans' Preference does not apply to positions covered by a direct hire authority.

To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings by the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.

To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP) , you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications and meet all eligibility, physical, medical, suitability, and all other requirements.

Background checks and security clearance

Security clearance

Drug test required

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Credentialing , Suitability/Fitness

Required Documents


Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builde r. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:
  • Job title
  • Name of employer
  • Beginning and ending dates of employment (month/day/year format)
  • Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
  • Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
  • Series and grade or equivalent (if a federal position)
  • If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.

    Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.

    For resume writing guidance, please visit the following resources: NIH Jobs website , USAJOBS Resource Center , and the USAJOBS Resume Writing Video Tutorial .

    You must submit a completed assessment questionnaire.

    Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

    Visit our websites to claim selection priority through the Career Transition Assistance Program (CTAP) or the Interagency Career Transition Assistance Program (ICTAP):
    • CTAP:
    • ICTAP:
    If you do not provide the required information, we will assume you are not eligible or you do not wish to be considered for any preference or eligibility.

    Please do not submit any other supplementary documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

    If you are relying on your education to meet qualification requirements:

    Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

    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.

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