Job Summary:

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services you can give back to your community, state, and country by making a difference in the lives of American’s everywhere. Join HHS and help to make our world healthier, safer and better for all Americans.

The Food and Drug Administration (FDA) is a scientific law enforcement Agency with the responsibility to protect the public health of the Nation’s 300+ million consumers as it may be affected by foods and food additives, drugs, biological products, cosmetics, medical devices, and ionizing and non-ionizing radiation emitting products and substances.

FDA’s Center for Drug Evaluation and Research (CDER) promotes and protects the Nation’s public health by planning, developing, and administering policies and programs related to the safety, efficacy and labeling of all drug products for human use. CDER’s activities impact national and international drug-related science. CDER frequently advises other nations on technical scientific issues related to human drug product development.

The FDA’s Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science (OPS), Office of Testing and Research (OTR) is searching of a Director of its Division of Applied Pharmacology Research (D/DAPR) at its FDA’s Research Laboratory in White Oak, Maryland.

The Director, Division of Pharmacology Research is the Office/Center’s principal advisor on all matters involved in planning and conducting laboratory research in pharmacology, toxicology or closely related fields; and he/she conducts an active research program and directs research scientists engaged in a broad range of pharmacologic research designed to ensure drug safety and efficacy. As a recognized expert, the incumbent participates fully in policy formulation; planning and evaluating programs, including oversight of pharmacology laboratory research activities to insure compliance with the FDA Critical Path Initiative to assess drug safety and efficacy and that major center decisions are science-based. The incumbent maintains contact with the “state of science” in order to identify and integrate the most advanced research theory and/or practice in pharmacology/toxicology science into the Center’s drug regulatory programs.

Major Duties:
If selected for this position, you will:
Conduct an active research program and direct research scientists engaged in a broad range of pharmacologic research designed to ensure drug safety and efficacy. These areas may include: (a) drug and environmental chemical interactions with drug metabolizing enzymes and transporters leading to altered drug pharmacokinetics; (b) emerging molecular biological techniques such as genomics, proteomics, and metabanomics; (c) pharmacogenetics and individualization of drug therapy; (d) safety evaluations of nanotechnology drug products; (e) identification of clinically relevant biomarkers and the mechanisms leading to adverse drug effects; and (f) neuron endocrine relationships, and the effects of drugs on human behavior.

Serve as an expert and scientific advisor and is recognized as a national authority in the areas of basic and applied pharmacological research. As the recognized expert, participate in resolving unique, far-reaching and/or previously unresolved problems and issues involved with planning and conducting laboratory research to investigate the nature and properties of pharmacologically significant substances in biological systems. Analyze, evaluate, consult and participate in making final decisions that become accepted Center research procedures.

Provide expert advice and mentoring to the drug review divisions and other scientific and regulatory units of the Center on drug pharmacology and toxicology. Monitor, oversee and coordinate the development and execution of relevant pharmacology/toxicology laboratory research programs. Exercise primary technical authority in response to recommendations of subordinate staff on unusual/complex problems and highly technical issues surrounding applied pharmacology/toxicology research.

Provide leadership and technical direction in developing and coordinating all applied laboratory pharmacological drug research programs and policies of the Food and Drug Administration and the implementation of new programs. Devise and validate biological methods which can establish a pharmacological understanding of clinical drug effects and which can stimulate critical rate-limiting steps in the drug development process. Correlate bio-analytical findings with results of new physicochemical methods of dug analysis. Plan and conduct research to investigate the utility of diverse preclinical animal and biochemical systems for the accurate prediction of the clinical effects of drug products. Develop standards and validate methods designed to enhance the Center’s programs and professional competence of the staff.

Formulate authoritative advice, options, alternatives, and recommends action for ultimate approval by the Director, OTR and other high level CDER and FDA officials when major departure from established policy is indicated and participate with these senior level officials in arriving at scientifically supportable decisions in the pharmacological research areas.

Provide expert scientific and knowledge based on technical consultations to the OTR and OPS Directors, the Center Director, the FDA Commissioner and other high level agency and DHHS officials on program status, plans, trends and significant problems related to applied pharmacological and toxicological research. Participate in intra/inter-Agency task groups and/or technical working groups as a FDA expert in applied pharmacological research activities.

Represent CDER and FDA at scientific, medical, and academic national and international forums. Represents the U.S. Government on problems and issues pertaining to pharmacological/toxicological research in meetings with counterpart foreign officials, government agencies and health professionals.

Serves as a focal point for the regulated pharmaceutical industry and academia in developing common interest research efforts to leverage resources and to support the development of appropriate regulatory guidance and policy. Articulate and coordinate pharmacological and toxicological research issues.

Qualifications:

To be eligible for appointment in the Senior Biomedical Research Service (SBRS), candidates must meet the U.S. Office of Personnel Management’s qualification standards for appointment at the GS-15 level in the General Service and must have earned a doctoral level degree.
This position requires a doctoral level knowledge of pharmacology, biomedical engineering, clinical pharmacology or closely related fields and an extensive knowledge in one or more of the following: pharmacology, physiology, pharmacodynamics, biopharmaceutics, toxicology and/or pharmacokinetics, with a strong record of peer-reviewed original research. Applicants should possess a national reputation in pharmacologic research, and established record of research and publications, and experience in managing multi-disciplinary scientists.
You will need to successfully complete a background investigation before you can be appointed into this position.

Conditions of Employment: This position within FDA is subject to strict restrictions on financial holdings (FDA regulated financial holdings). Applicants are advised to seek additional information from the Ethics and Integrity Staff, Office of Management Programs, Office of Management at (301) 827-5514 prior to accepting such a position.
Candidates must address the following qualification factors in addition to providing a resume or curriculum vitae.

Mandatory Requirements

1. Administrative or managerial experience that demonstrates sound judgments, strong leadership abilities in a scientific or public health environment, and leadership competence and abilities to: develop complex and basic program goals, and assure that agency goals and priorities are considered in carrying out the functional responsibilities of the organization; direct and guide projects, including long-term and short-term planning; establish objectives and priorities; conduct periodic program assessments; and plan and direct the work of a scientific, technical, and subordinate staff.
2. Experience that indicates the ability to communicate and effectively interact with high level government officials, the scientific/academic communities, medical or health related groups, congressional representatives, and other top level representatives of counterpart Federal agencies, foreign governments, representatives of the regulated industry, and others.

Desirable Requirements

1. Knowledge in drug pharmacology and toxicology including the mechanisms of drug metabolism, drug transporters and drug-drug or drug-environmental chemical interactions.
2. Knowledge of pharmacogenomics, proteomics, and metabanomics relevant to drug therapy and safety.
3. Knowledge and understanding of the provisions, limitations and practical application of Food and Drug laws and regulation related to human drugs and pharmacology.
4. Training, professional development, and outside professional activities that provide evidence of initiative, resourcefulness and potential for effective job performance and honors, awards or other recognition for performance or contributions based on managerial excellence.