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Branch Chief (Hematology)

Company: Carrington & Carrington, Ltd.
Location: Silver Spring
Posted on: September 22, 2022

Job Description:

10903 New Hampshire Avenue, Silver Spring, Maryland, 20903 Full-time $180,000 per year Summary The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), is actively recruiting Board Eligible/Board Certified Pediatric or Adult Hematologist with a minimum of 5 years of graduate training or equivalent experience in either malignant or nonmalignant hematologic conditions to serve as a Branch Chief in our Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT). About this job The Branch Chief guides the clinical review program which include evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders. Multiple selections will be made from this announcement (Malignant Hematology Branch Chief and Nonmalignant Hematology Branch Chief) Note : This position is being filled under a stream-lined 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 be paid under the provisions of this authority. This job is open to the following levels: Public (U.S. Citizens and Nationals) Career transition (CTAP, ICTAP, RPL) Introduction The Food and Drug Administration (FDA or Agency) 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 Center for Biologics Evaluation and Research (CBER) mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. The Office of Tissues and Advanced Therapies (OTAT) plans and conducts research related to the development, manufacture, and testing of cellular, gene therapy (including those utilizing naturally occurring viral vectors and those prepared by genetic engineering and synthetic procedures), therapeutic vaccines, and plasma-derived and coagulation products in order to develop and maintain a scientific base for establishing standards for safety, purity, potency, and effectiveness. Duties/Responsibilities The incumbent will serve as Supervisory Physician (Hematology) responsible for managing and supervising staff and overseeing work focused on hematologic conditions. Depending on the branch, responsibilities will include oversight of either malignant hematologic disorders or nonmalignant hematologic disorders. Develops policy and/or research regarding hematology related clinical issues, such as trial design issues and safety. Oversees the development of written policies, identifies critical problems in clinical trial methodology. Directs the clinical review program in evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders. Provides guidance to sponsors regarding all phases of clinical development. Engages in developing hematology related clinical guidelines and procedures. Determines the appropriateness of the design with respect to the objectives of the study and the development of the drugs or devices. Supervises the review and evaluation of clinical data submitted in marketing applications. Evaluates reports of clinical trials in humans for evidence of safety and effectiveness. Qualifications Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent A current, active, full, and unrestricted license or registration as a Physician Graduate training (1-year internship, residency, and fellowship) Must have five-years of graduate training and experience in hematological disorders and non-malignant hematology Board certification in Hematology/Oncology preferred Must be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.). How to Apply NOTE TO ALL APPLICANTS: We do not receive applications through SimplyHired Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your active medical license, copy of your transcripts (unofficial), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with CURES CBER/OTAT/DCEPT Branch Chiefs in the subject line to: CBERHumanCapital fda.hhs. gov as well as to Evan. Cooney fda.hhs. gov. Applications will be accepted through August 29, 2022. Working at the FDA Working at FDA means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, committed, FDA employees tackle unprecedented challenges to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and that keep our food safe and reduce harm from all regulated tobacco products. We believe in collaboration, mutual respect, open communication, and opportunity for growth. If youre seeking to make a difference in the world, visit Jobs and Training at FDA - FDA to find your next career. 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. Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Apply for this position Required First Name Last Name Email NOTE: WE CANNOT ACCEPT APPLICATIONS ON SIMPLYHIRED. Submit your CV and required documents as well as any questions directly to : Evan. Cooneyfda.hhs. gov Resume Drag and drop files here to upload or choose file Supported file types include .pdf, .doc, .docx, and .rtf

Keywords: Carrington & Carrington, Ltd., Silver Spring , Branch Chief (Hematology), Other , Silver Spring, Maryland

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