Associate Center Director for Drug Safety (DSO)
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 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 mission of the Office of the Center Director (OCD) is to provide leadership and overall direction to all CDER activities to ensure that the mission of the Center is accomplished. CDER makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.
As the Associate Center Director for Drug Safety (DSO), the incumbent is responsible for the management of significant and/or controversial drug safety issues, as well as creation and oversight of CDER processes for management of all cross-Office and cross-Center safety issues. . Provides overall direction to the Center in the formulation, development, implementation, and oversight of drug safety processes. Ensures transparent communication of policies, procedures, and decisions related to CDER safety programs and actions across the Center and to other stakeholders.
Provides direction, oversight, and technical expertise on critical aspects of drug safety, particularly those that involve broad, controversial, sensitive, and complex subjects requiring technical expertise, integrated evaluation throughout Center components, and sensitive coordination with other Agency components because of their potential impact on FDA programs and public health.
Handles highly complex and controversial assignments of national scope and significance, thereby ensuring that regulations and policies developed are consistent with the statutory requirements and existing policy. Serves as a point of contact on drug safety inquiries from Congress, other Federal agencies, and other outside groups and stakeholders. Develops and implements drug safety-related policies, in coordination with the Offices of Medical Policy and Regulatory Policy, and in consultation with other offices, as appropriate.
Advises the Commissioner, Center Director, senior FDA and HHS officials, and others on matters involving drug safety that have an impact on policy development and execution and long-range programs goals.
Provides oversight, direction, and supervision to the Drug Safety Oversight Board (DSOB) and its staff, an internal government committee, that provides program-independent oversight and advice to the Center Director on the management of emerging drug safety issues.
Serves on the CDER Drug Risk Management Board (DRMB) and provides oversight, direction, and supervision for staff supporting all DRMB activities).
Directs special projects, studies, or activities of concern to the Center Director and/or Commissioner which may involve the coordinated effort of several Center components.
Supervisory Responsibilities: Provides leadership, management oversight, and both administrative and technical supervision twenty-five percent of the time to an expert professional multi-disciplinary staff within the Office. Develops and sets long- range plans and schedules for the work of DSO, assures implementation by subordinate team leaders of the goals and objectives of DSO, determines goals and objectives that need additional emphasis, determines the best approach and solution for resolving drug safety issues, and plans for long range budget, staffing, and other resource needs.
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. Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice. FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter. Males born after December 31, 1959 must be registered with the Selective Service. One-year supervisory probationary period may be required. Financial Disclosure may be required. Ethics Clearance may be required. Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
Qualifications To be placed into a Cures position, candidates must meet the following criteria:
- Scientific, Technical, and Professional Fields Qualified and Outstanding Candidates Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Supervisory Physician, AD-0602 Series
Degree: Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association); Association of American Medical Colleges; Liaison Committee on Medical Education; Commission on Osteopathic College Accreditation of the American Osteopathic Association, or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates, a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S. Medical Licensing Examination.
Candidates must meet education requirements in a scientific discipline and the Physician series 0602, directly related to the position being filled, in accordance with the Office of Personnel Management (OPM) qualification standards. For more information, please see: OPM Occupational Series Qualification Requirements.
Supervisory General Health Scientist, AD-0601 Series
Degree: 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. For more information, please see: OPM Occupational Series Qualification Requirements
Our ideal candidate will possess:
- Experience and leadership in programmatic drug safety and drug development activities. Experience in leading and overseeing initiatives or strategies in support of programmatic drug safety activities. Demonstrated previous senior leadership experience, and sound judgement. Ability to function within a regulatory environment and problem solve to meet challenging demands. Identifies the internal and external politics that impact the work of the organization. Perceives organizational and political reality and acts accordingly. Builds and manages workforce based on organizational goals, budget considerations, and staffing needs. Ensures that employees are appropriately recruited, selected, appraised, and rewarded; takes action to address performance problems. Manages a multi-sector workforce and a variety of work situations.
Desired Professional Experience:
Our ideal candidate will possess:
- Experience applying knowledge of FDA, European Union (EU), International Conference on Harmonization (ICH) and other global regulatory requirements for safety reporting and safety data and risk management. Experience in benefit-risk assessment and risk management in pre- and post-market stages. Develops networks and builds alliances; collaborates across boundaries to build strategic relationships and achieve common goals, by garnering agreement between center leaders and stakeholders. Strong interpersonal skills. Ability to establish an organizational vision and to implement it in a continuously changing environment. A strategic thinker that can translate the strategy into an operational plan. (Possess a broad view of safety across the life cycle pre and post market)
Education Transcripts SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA employee, you are not exempt from transcript requirements.
FOREIGN EDUCATION: 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; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
Security Clearance Requirements Background Investigation/Security Clearance Requirements: Non-Sensitive- High Risk
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.
Vaccination Requirements To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a federal job announcement includes the requirement that applicants must be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply. Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
Ethics Clearance Requirements This position may require financial disclosure reporting and 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. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
Equal Employment Opportunity Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of 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.
Reasonable Accommodation 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. 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.
E-Verify The Food and Drug Administration 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.
How to Apply:
Click apply to submit resume.
Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (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 Reference ID: E-22-722-G.
Announcement Contact For questions regarding this Cures position, please contact Ashley Corum-Lawson, Supervisory Administrative Officer, Ashley.Corumlawson@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.