Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Drug Evaluation and Research (CDER)

Office of Executive Programs (OEP)

Advisory Committee Management Branch (ACMB)

Division of Advisory Committee and Consultant Management (DACCM)

__________________________________________________________________

Position: Supervisory Health Science Administrator (Branch Chief)

Series: AD-0601

Location(s): Silver Spring, MD

Travel Requirements: 25% or less

Application Period: February 9^th, 2021- February 23^rd, 2021

Salary: Starting salary of $122,530 (CURES Band D)

Conditions of Employment: United States Citizenship is required.

Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.

Special Notes:

This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and compensated under the provisions of the authority. Additional information on 21st Century Cures Act can be found here.

Introduction:

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs. CDER is looking for leaders with a commitment to scientific excellence and innovative thinking to lead a dynamic and diverse organization.

The Office of Executive Programs (OEP) oversees a variety of Center-wide programs, including executive project management, the Center’s executive secretariat function, scientific advisory committees, training and development, CDER’s ombudsman, and program and administrative management.

Position Summary:

The Supervisory Health Scientist Administrator, Branch Chief for the Advisory Committee Management Branch (ACMB) is in the Division of Advisory Committee and Consultant Management (DACCM), Office of Executive Programs (OEP), Center for Drug Evaluation and Research (CDER). Along with the technical knowledge and guidance required for this position, the Health Scientist Administrator will also serve as a Designated Federal Officer, (DFO) for the advisory committees.

Supervisory responsibilities:

• Manages multiple projects and provides leadership to approximately 12 employees.
• Assists the DACCM Director in organizing work, establishing priorities, and administering DACCM operations.
• Approves leave and recommends performance standards and ratings;
• Plans work to be accomplished by subordinates, sets and adjusts priorities and prepares schedules for work;
• Assigns work to subordinates based upon priorities, selective consideration of the difficulty and requirements of assignments and the capabilities of employees;
• Manages and coordinates the employee performance management and appraisal systems to include developing performance standards and evaluating work performance of subordinates;
• Gives advice, counsel, or instruction to employees on both work and administrative matters; interviews candidates for positions in the Office;
• Recommends appointment, promotion, or reassignment to such positions; hears and resolves complaints from employees; and effects minor disciplinary measures such as warnings and reprimands;
• Coordinates and evaluates the training needs of the professional staff in the DACCM; identifies developmental and training needs of employees, providing or arranging for same. This includes reviewing and recommending professional development opportunities.

Duties/Responsibilities:

Coordinates and counsels with Center management on the use of advisory committees, scientific consultants, and relevant resources, or policy decisions and determinations made by the DACCM Director and higher-level managers of the Centers.

Responsible for the Branch’s performance of the preliminary administrative and scientific review of Investigational New Drugs (IND), New Drug Applications (NDA) licensing, or other health science issues to be presented to fully understand the scientific basis for the advice and recommendation that the Agency seeks for a specific application(s). Assesses the use of the results and the recommendations for the appropriate use of external expertise and specific experts for assigned advisory committee meeting, agency directed assignment, or committee membership.

Responsible for the Branch’s performance of in-depth research using a variety of sources such as U.S. treatment guidelines,Pubmed, Up-to-date, ClinicalTrials.gov on current clinical practice guidelines and product use related to specific advisory committee meeting topics. Sponsors DFOs’ collaboration and leadership of discussions with other Agency professionals in the identification of products and firms that could be affected by the outcome of advisory committee meetings and agency directed assignments. Ensures that DFOs inform participants (Chair) of the findings to ensure meeting participants and decision makers are notified of approved products, off-label products and pending IND/NDAs for the proposed indication that could potentially be impacted by the outcome of an Advisory Committee (AC) meeting. Incumbent participates in the performance of these tasks on a temporary basis as necessary.

Responsible for advising the Office of New Drugs (OND) review divisions on the factors for a convening an advisory committee for a specific application, and applications generally. Requires an understanding of novel clinical trial design and use of surrogate endpoints; an ability to identify and discuss significant issues on the safety and/or effectiveness of the drug or biologic; and an ability to identify and discuss significant public health questions on the role of the drug(s) or biologic(s) in the diagnosis, cure, mitigation, treatment, or prevention of a disease. Ensures that use the advisory committee system is maximized for the greatest public health benefit.

Exercises specific delegated authority on an ongoing basis for a variety of functions and projects and performs or directs such special assignments for the DAACM Director. These assignments are often on an emergency basis of a complex nature without precedence and require creative solutions which address all regulatory, legal, and scientific aspects.

Identifies and assesses emerging, standing, complex, or precedent-setting issues which impact DACCM and Center policies, procedures, and resources. Advises the DAACM Director of potential or emerging technological and regulatory issues and the need to formulate appropriate program responses to address these issues. More specifically, adjusting Advisory Committee procedures to accommodate the application review performance goals and procedures established under reauthorizations of the Prescription Drug User Fee Act (PDUFA).

Develops and provides technical advice and interpretation of regulations, policies, and procedures relating to committees and conflict of interest; ensures the integrity of the advisory process; and ensures the establishment of advisory committees and the appointments of members, consultants, and experts are properly affected. Ensures the proper operation, direction, and coordination of all DACCM advisory committees. More specifically, advise related to ensuring that the Center meets its responsibility under the Food and Drug Administration Amendments Act of 2007, to hold advisory committee meetings for all new molecular entities and original biologic licensing applications, unless an adequate justification explaining the decision not to hold a meeting is provided.

As the recognized expert in advisory committee management, establishes policy with respect to committee management and the conduct of meetings, consultant use, and conflict of interest (COI) issues. Provides technical and procedural information to the consultants (committee members) as background for reviewing and evaluating issues and collects and provides information considered to be essential for members to have in order to adequately evaluate the assignment. Maintains awareness of FDA’s legislative and regulatory mandates and executes a proper scientific or technical direction in order to achieve the most satisfactory results from the committee.

EEO Responsibility

The incumbent is responsible for furthering the goals of equal employment opportunity (EEO) by taking positive steps to assure the accomplishment of affirmative action objectives and by adhering to non-discriminatory employee practices regarding race, color, religion, sex, national origin, age, or handicap. Specifically, as a manager, incumbent initiates non- discriminatory practices and affirmative action for the area under his/her supervision in the following: 1) merit promotion of employees and recruitment and hiring of applications; 2) fair treatment of all employees; 3) encouragement and recognition of employee achievements; 4) career development of employees; and 5) full utilization of their skills.

Equal Employment Opportunity Policy

The United States Government does not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Click here to find out additional information about the Equal Employment Opportunity (EEO) for federal employees & job applicants.

Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.

Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:

• An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job
• An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace
• And an employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.

You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

Learn more about disability employment and reasonable accommodations or how to contact an agency.

Education Requirement: AD-601

Candidates must meet education requirements of a bachelor’s or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.

Position’s Preferred Skills and Experience: AD-601 (Band D)

Demonstrated analytical ability, judgement, discretion in executing Food & Drug Law activities.

Knowledge of Federal Statutes and Regulations, including but not limited to:

• The Federal Advisory Committee Act;
• Federal Food, Drug, and Cosmetic Act;
• Federal Conflict of Interest Statutes; or
• Other relevant or transferrable areas of federal law and rulemaking. Demonstrated ability to work collaboratively across organizational boundaries.Demonstrated skill in the analysis, evaluation, and interpretation of complex Federal statutes and regulations.

Conditions of Employment

1.      Security Clearance

If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required later.

Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action.

2.      Ethics Requirements

This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Confidential Disclosure Report (OGE 450 or 278) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

3.      How to Apply

Submit resume with cover letter and copy of transcripts to CDER-OCD-OEP-Hires@fda.hhs.gov,by February 23rd, 2021. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions please contact Ashley Corum-Lawson, Supervisory Administrative Officer, Ashley.Corumlawson@fda.hhs.gov. Please reference Job Code: S-20-182-D

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.