Supervisory Physician (Hematology)

Company/Institution: FDA/Center for Biologics Evaluation and Research
Location: Silver Spring, MD, USA
Degree Requirements: MD Salary: $150,000 - $199,999
Job Type: Research, Allied Health, Other Posted: November 23, 2021
Job Setting: Other Application Period: November 23-December 22, 2021

About this job: This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), in White Oak, MD. Note: Title 38 Physician and Dentist Pay (PDP) is authorized in order to recruit and retain highly qualified Physicians. Salary ranges shown include the OPM GS Base Salary and FDA base market pay. Additional market pay may be applied based on medical specialty. This job is open to the following levels: • Public (U.S. Citizens and Nationals) • Career transition (CTAP, ICTAP, RPL) View the full announcement for this position here: https://www.usajobs.gov/GetJob/ViewDetails/619060000 Summary: The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring that all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and tobacco and radiation emitting devices are safe and effective. The mission of the Center for Biologics Evaluation and Research (CBER) within the FDA is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. Through our mission, we also seek to protect the public against the threats of emerging infectious diseases and bioterrorism. CBER’s Office of Tissues and Advanced Therapies (OTAT) does this by ensuring the safety, potency, effectiveness of a variety of products, including purified and recombinant therapeutic proteins for hematology, cellular therapies, gene therapies, and tissue products for the prevention, diagnosis, and treatment of human disease. This program oversees and provides guidance on product development programs through all phases of product development for products under the program’s jurisdiction. The program decisions impact FDA and CBER’s mission to protect and advance public health. We are looking for someone to be responsible for managing and directing a professional regulatory review program, which is a major activity within a Center regulatory review Office/Division. 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.). Responsibilities: • 40% - Work with other FDA centers and agencies on consultative and collaborative reviews. Develop policy and/or research regarding clinical issues, such as trail design issues and safety. • 30% - Obtain resources and identify strategic objectives for the organization. Supervise occupational specific technical administrative direction subordinate employees performing the work and functions of the organization. • 30% - Provide guidance to sponsors regarding all phases of clinical development. Direct the clinical review program, which includes evaluating clinical data and protocols that involve biological products for the treatment of hematological disorders. • Perform other duties as assigned • The position requires up to 25% travel or less Duties: • The incumbent will serve as Supervisory Physician (Hematology) responsible for managing and supervising staff and overseeing work focused on the Nonmalignant Hematology functional area. • 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. 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 you’re 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. Supervisory status: Yes Promotion Potential: 15 Seniority Level: Supervisor Industry: • Healthcare • Government Administration Employment Type Full-time Job Functions • Management • Healthcare Salary Range:$174,060 - $207,198 per year

How to Apply

How to Apply: If you’re seeking a challenging and rewarding career opportunity, we invite you to apply today by completing the following steps: 1. Submit your electronic resume or curriculum vitae and supporting documentation to CBER Recruitment at cber.employment@fda.hhs.gov and carbon-copy Tejashri Purohit-Sheth at tejashri.purohit-sheth@fda.hhs.gov. Supporting documentation may include: bibliography, summary of research accomplishments, and names/contact information of three references. Please reference Job Title, Supervisory Physician (Hematology) in the subject line. 2. Create/Log-in to your USAJOBS account and apply to the official Supervisory Physician job opportunity announcement located on USAJobs.gov at https://www.usajobs.gov/GetJob/ViewDetails/619060000. For consideration, applications MUST be received by applying to the official job opportunity announcement located in the link above.

Contact Information

CBER Recruitment
10903 New Hampshire Ave
Silver Spring, MD 20993 USA
CBER.Employment@fda.hhs.fov

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