Branch Chief (Supervisory Physician)

The incumbent serves as the Branch Chief (Supervisory Physician) for the Malignant Hematology Branch (MHB) within the Division of Clinical Evaluation Hematology (DCEH) under the Office of Clinical Evaluation (OCE) and Office of Therapeutic Products (OTP). This position reports to the Director of DCEH. OTP is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies and other products regulated by OTP. Specifically, the Branch Chief (Supervisory Physician) will: Direct the clinical review program in the evaluation of clinical data and protocols related to biological products, particularly in cell and gene therapies, plasma derived products and devices, for the treatment of malignant hematologic disorders. Provide guidance to sponsors related to all the phases of clinical development. Develop clinical guidelines and procedures, Federal register statements, and special projects. Determine suitability of the design with respect to the objectives of the study and the development of the drugs or devices. Supervise the review and evaluation of clinical data submitted in marketing applications. Evaluate the reports of clinical trials in humans for evidence of safety and effectiveness. Provide guidance to sponsors in responses essential to the drug development in a timely and safe manner. Manage and supervise the Branch staff and oversee work pertaining to malignant hematologic conditions. Oversee activities related to malignant hematologic disorders. Develop policy and/or research regarding hematology-related clinical issues, such as trial design issues and safety. Oversee the development of written policies and identify critical problems in clinical trial methodology. Engage in the development of hematology-related clinical guidelines and procedures. Mentor and promote the professional development of members of the Branch.

In order to qualify for this Title 21 (Cures) position, the candidate(s) must meet the following requirements: Education: A degree from an accredited program or *institution in Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent. *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. AND 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 US or Canada. Desired Professional Experience/Qualifications: The experiences and qualifications listed below are considered preferable/desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position. Candidates would ideally have an M.D. or D.O. degree and be board-certified or board-eligible in adult or pediatric hematology. Clinical experience/expertise in malignant hematologic conditions. Experience in clinical trial design, analysis, and/or regulation. Ability to prioritize and make critical decisions. Developing short- and long-term programmatic goals. Work collaboratively with a diverse cadre of customers and stakeholders. Knowledge and understanding of current FDA regulations, policies, and procedures pertaining to safe and effective drugs and biologics. Experience monitoring trials of investigational agents for safety. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. How you will be evaluated: You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement: Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.

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