FDA - Physician - Radiation Oncologist

19 hours ago

Silver Spring, United States AE Strategies Full time
FDA - Physician - Radiation Oncologist

Department: Office of Specialty Medicine (OSM)

Employment Type: Full Time

Location: Silver Spring, MD

Description

AE Strategies has provided human capital management consulting to federal clients for the past 20 years.

The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies' role is to identify and pre-screen candidates, and then to introduce these candidates to hiring managers at the FDA.

IntroductionThe Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food-producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA's programs are national in scope and effect, and the agency's activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.

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 and prescription drugs, including biological therapeutics and generic drugs.

Functional Duties and Responsibilities
  • Serve as a Physician within a clinical review division to determine whether clinical trials of new drugs in humans related to infectious diseases 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 reactions 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 or not 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.
  • Assigned work in the area of medical specialty Infectious Disease, in as much as this is practicable based on the types of applications received. Drug submissions assigned for review will include drugs whose evaluation will be challenging and complex and require mature professional judgment. Physicians within the Division are considered to be the Agency's foremost specialists in assigned therapeutic areas and indications, and in appropriate clinical trial design for the evaluation of drugs intended to treat such conditions.
  • 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 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.
  • Keep abreast of the progress in medical and related sciences by reviewing the scientific literature, attending conferences, and participating in staff seminars, at which, cases and special topics are discussed. As appropriate, may contribute to such scientific literature, internal and external conferences, seminars, and workshops helping to advance clinical and scientific understanding in areas of her/his expertise.


Desired Education, Skills, or Experience

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.

Licensure
For all band levels and positions, applicants must possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.

Specialized Experience
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 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 therapeutic area.

Benefits

Full benefits package and paid time off

  • FDA - Physician - Gynecologic Oncology

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - Gynecologic OncologyDepartment: Office of Oncologic Diseases (OOD) Employment Type: Full Time Location: Silver Spring, MD Description The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies' role is to...

  • FDA - Physician - Radiology

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - RadiologyDepartment: Office of Specialty Medicine (OSM) Employment Type: Full Time Location: Silver Spring, MD Description AE Strategies has provided human capital management consulting to federal clients for the past 20 years. The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to...

  • FDA - Physician - Thoracic Oncology

    15 hours ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - Thoracic OncologyDepartment: Office of Oncologic Diseases (OOD) Employment Type: Full Time Location: Silver Spring, MD Description The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies' role is to...

  • FDA - Physician - Hematologic Oncology Leukemia

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - Hematologic Oncology LeukemiaDepartment: Office of Oncologic Diseases (OOD) Employment Type: Full Time Location: Silver Spring, MD Description The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies'...

  • FDA - Physician - Nuclear Medicine

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - Nuclear MedicineDepartment: Office of Specialty Medicine (OSM) Employment Type: Full Time Location: Silver Spring, MD Description AE Strategies has provided human capital management consulting to federal clients for the past 20 years. The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner,...

  • FDA - Physician - Gastroenterologist

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - GastroenterologistDepartment: Office of Immunology & Inflammation (OII) Employment Type: Full Time Location: Silver Spring, MD Description The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies' role is...

  • FDA - Physician - Urologic Oncology

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - Urologic OncologyDepartment: Office of Oncologic Diseases (OOD) Employment Type: Full Time Location: Silver Spring, MD Description The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies' role is to...

  • FDA - Physician - Clinical Reviewer - Dermatologist

    8 months ago

    Silver Spring, United States AE Strategies Full time

    Medical officers at FDA perform duties that:ensuring all human drugs manufactured for interstate sale are safe and effective with truthful and informative product labelingensuring the safety, potency, purity and effectiveness of vaccines, blood products, certain diagnostic products and other biological and biotechnology-derived human productsensuring the...

  • FDA - Physician - Anesthesiology, Addiction and Pain Medicine

    3 weeks ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - Anesthesiology, Addiction and Pain MedicineDepartment: Office of Neurology (ON) Employment Type: Full Time Location: Silver Spring, MD Description The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies'...

  • FDA - Physician - Hematologic Oncology Lymphoma Myeloma

    1 day ago

    Silver Spring, United States AE Strategies Full time

    FDA - Physician - Hematologic Oncology Lymphoma MyelomaDepartment: Office of Oncologic Diseases (OOD) Employment Type: Full Time Location: Silver Spring, MD Description The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE...

  • FDA - Physician - Trial Reviewer - Urologist

    3 months ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Trial Reviewer - Urologist Oncology

    6 months ago

    Silver Spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Trial Reviewer - Hematology Oncology

    1 month ago

    silver spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • FDA - Physician - Trial Reviewer - Hematology Oncology

    2 months ago

    silver spring, United States AE Strategies Full time

    The Clinical Trial Reviewer is a full-time physician position with the FDA. It is a hybrid role where candidates must live within commutable distance of the FDA Headquarters in Silver Spring, MD and willing to report to the office at least one day per week. The team follows traditional working hours with no overtime or weekend hours.A Day in the Life:As an...

  • Physician Radiation Oncology

    2 months ago

    Silver Spring, United States US Oncology Network-wide Career Opportunities Full time

    OverviewAre you looking for a Great place to work? Our team at Maryland Oncology Hematology is looking for "star" talent. If you believe you have what it takes to create a rewarding experience for our Physicians, patients, and team members, we would enjoy the opportunity to speak with you!!! Maryland Oncology Hematology is dedicated to providing the most...

  • Radiation Therapist

    2 months ago

    Spring Branch, United States SkinCure Oncology Full time

    *Seeking Radiation Therapist: FULL-TIME**Radiation Therapist Summary:** We are a superficial radiotherapy (SRT) provider operating in the Dermatology arena, with a focus on quality and customer service. Founded in 2016, we are poised to become the largest provider of SRT for Dermatologists in the U.S. Our core competency centers on striving to be the...

  • Medical Oncologist

    4 days ago

    Silver Spring, Maryland, United States Trinity Health Full time

    Company Overview: Holy Cross Hospital is seeking a highly skilled Hematology/Oncology Physician to join its brand-new Cancer Center in Wheaton, Maryland. Our state-of-the-art facility offers the latest radiation technology and is co-located with our tertiary care centers.">Estimated Salary: $250,000 - $400,000 per year

  • Radiation Therapist

    2 weeks ago

    Spring Branch, United States SimplyApply Full time

    Seeking Radiation Therapist: FULL-TIME Radiation Therapist Summary: We are a superficial radiotherapy (SRT) provider operating in the Dermatology arena, with a focus on quality and customer service. Founded in 2016, we are poised to become the largest provider of SRT for Dermatologists in the U.S. Our core competency centers on striving to be the...

  • Radiation Therapist

    1 month ago

    Spring Hill, United States SkinCure Oncology Full time

    Seeking Radiation Therapist: FULL-TIME Radiation Therapist Summary: We are a superficial radiotherapy (SRT) provider operating in the Dermatology arena, with a focus on quality and customer service. Founded in 2016, we are poised to become the largest provider of SRT for Dermatologists in the U.S. Our core competency centers on striving to be the...

  • Radiation Therapist

    3 weeks ago

    Spring Hill, United States SkinCure Oncology Full time

    *Seeking Radiation Therapist: FULL-TIME*Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.*Radiation Therapist Summary:** We are a superficial radiotherapy (SRT) provider operating in the Dermatology arena, with a focus on quality and customer service. Founded in 2016, we are...