Physician

These positions are in the Center for Drug Evaluation and Research (CDER), Office of New Drugs, Office of Oncologic Diseases. The mission 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. This position is an FDA Physician within a clinical review division responsible for evaluating new oncology drugs and therapies across their full regulatory lifecycle. Core duties include reviewing Investigational New Drug (IND) applications to assess whether proposed human clinical trials in oncology and related therapeutic areas are scientifically sound and adequately supported by preclinical data and evaluating New Drug Applications (NDAs) including supplements and amendments to determine approvability based on safety and efficacy evidence, accurate labeling, and appropriate use warnings. The physician also oversees post‑market safety through periodic and adverse event reports, makes decisions on label expansions and safety updates for approved oncology drugs, and collaborates with a multidisciplinary team of pharmacologists, chemists, and other specialists to reach sound regulatory conclusions. Additional responsibilities include engaging with industry sponsors, consulting with internal and external scientific experts on complex oncology and medical issues, contributing to regulatory policy and guidance development in areas of unmet oncologic need, and maintaining and advancing expertise in oncology and assigned therapeutic areas through ongoing review of scientific literature, conferences, and seminars. The incumbent is regarded as one of the Agency's foremost specialists in oncology and their assigned therapeutic area and is expected to exercise mature, independent professional judgment on challenging and complex drug submissions. Serve as a Physician within a clinical review division to determine whether clinical trials of new drugs in humans related to areas are soundly conceived, and supported by prior animal testing and other controls adequate to justify tests in humans review applications by manufacturers for permission to market new drugs for general use should be approved based on an evaluation of the evidence of their safety and effectiveness; and ensure proposed labeling contains truthful claims for safety and effectiveness, and adequate directions for use and warnings against misuse. Review supplements and amendments to previously approved NDAs, which must be thoroughly reviewed for efficacy and safety in acting on a supplement; review periodic reports submitted by sponsors on drugs approved for marketing; review adverse reaction and other safety reports. Make medical decisions in each case as to whether the indicated population of a previously approved NDA should be expanded, whether changes in the labeling reflecting new safety information is required, and whether the information submitted and otherwise available supports approval of the supplement. Review the summaries of pharmacologists and chemists as part of the decision‑making process and determine whether to approve an application. Make science‑based recommendations that an NDA or a supplement submission be approved, is incomplete on specific points, or not be approved such an IND be continued, modified, or placed on clinical hold. Contribute on a multi‑disciplinary scientific team to arrive at a conclusive medical opinion; considers a variety of types of information, such as research findings and clinical studies. Provide authoritative comments on research designs and new endpoints or clinical procedures and, in meetings with industry sponsors of an application. Prepare correspondence (e.g., information requests) requesting additional data on when deficiencies or areas of unclarity can be addressed with additional information. Consult with other medical specialists and scientists within FDA, and other government agencies, universities, hospitals, and Clinics to address areas of uncertainty or for input on complex and challenging medical issues bearing on applications in IND development, or in areas where there is unmet medical need and regulatory policy and guidance is needed. Qualifications Education: A degree from an accredited program or institution in Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent. If the degree is from a foreign medical school, it must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates. Graduate Training: In addition to a degree, a candidate must have had at least one year of supervised experience providing direct service in a clinical setting. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada. Preferred Qualifications: Skill in applying their clinical and scientific expertise to complex multifaceted medical problems such as in benefit / risk determinations. Understanding of advanced professional theories, principles, concepts, standards, and methods sufficient to conceive and apply to unique circumstances and develop an understanding of these new circumstances, and to determine appropriate actions. Ability to resolve unique or novel problems and conditions, thereby addressing complex and challenging problems in the context of regulatory review of medical products. Knowledge of clinical, medical, and scientific literature and current clinical activities relating to new drugs and biologics in the assigned Oncology area. #J-18808-Ljbffr