Team Lead - Physician

Company/Institution: FDA/Center for Biologics Evaluation and Research
Location: Silver Spring, MD, USA
Degree Requirements: MD, DO Salary: $200,000 - $249,999
Job Type: Research, Academic/Administrative, Other Posted: December 1, 2020
Job Setting: Other Application Period: December 1, 2020-April 29, 2021

OFFICE OF TISSUES AND ADVANCED THERAPIES (OTAT) CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) FOOD AND DRUG ADMINISTRATION (FDA) DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Become a part of an agency that touches the lives of every American! The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies’ (OTAT) Division of Clinical Evaluations and Pharmacology/Toxicology (DCEPT) is recruiting to fill the position of the Team Lead - Physician in the Clinical Hematology Branch (CHB). OTAT’s mission is to protect and enhance the health of the public through the evaluation of clinical studies and scientific data in support of investigational new drug and marketing applications of biological products. What Does CBER Have to Offer You? CBER is committed to facilitating the development of new biological products, to include but not limited to cell and gene therapies, plasma protein therapeutics, and select medical devices for a broad range of complex and often times life-threatening diseases as well as rare diseases. By joining CBER, you will fuel your own passions and use your many talents, skills, and experiences to help CBER successfully navigate the challenges and opportunities of 21st Century medicine. This position is excellent for a physician who is ready to transition into non-clinical work with an interest in drug development, review of clinical trials, and critical interpretation of study design and clinical data analysis. Responsibilities: As the Team Lead - Physician, duties may include but are not limit to: • Serving as the principal advisor to the Branch Chief and the Division Director for all classes of biologic products that concern hematologic disorders. • Evaluating all clinical data submitted to OTAT by sponsors of biologic products and advanced therapies to support Biologics License Applications (BLAs), Investigational New Drug applications (INDs), Investigational Device Exemptions (IDEs), reports of pre-and post-marking trials and studies and other related regulatory submissions. • Consulting other offices in CBER and other Centers at FDA on complex issues related to advanced therapies, including cell and gene therapy and other therapeutic biological products and devices. • Leading a team of other professional staffed medical professionals through GP-14 and GP-15 grade levels. • Representing the agency at meetings with academic and industry sponsors and at medical conferences. Qualifications: Physician, GP-0602: Must be a U.S. citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent from a school in the United States or Canada. The degree must have been approved by a recognized accrediting body at the time the degree was obtained. A Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States may be demonstrated by the Educational Commission for Foreign Medical Graduates (external link), or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country. Candidates for Civil Service or U.S. Commissioned Corps must possess a valid license to practice medicine in any state in the U.S. It is highly desired that the prospective candidate has eligible Board Certification. Preferred Specialized Experience: We highly encourage candidates with the following experience and qualifications in: • Training in pediatric or adult hematology with experience in malignant and/or non-malignant hematologic disorders; • Experience in the design, conduct, and interpretation of clinical trials; • Experience in effectively managing multidisciplinary scientific staffs; • Proficient in applying professional knowledge and expertise to solve difficult problems; • Excellent skills in oral and written communication; • Cognizant of applicable Federal laws, FDA regulations, and associated guidance. Regulatory experience is preferred. Licensure: Applicant 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. Salary: Salary is equivalent to GS-0602-15, plus physician market pay (Title 38), and is commensurate with education/experience. U.S. Public Health Service Commissioned Corps Officers may also apply. Location: FDA White Oak Campus in Silver Spring, MD

About the Employer

The Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

How to Apply

How to Apply: If you’re seeking a challenging and rewarding career opportunity, we invite you to apply today by submitting your electronic resume or curriculum vitae and supporting documentation to CBER Recruitment at cber.employment@fda.hhs.gov. Supporting documentation may include: bibliography, summary of research accomplishments, and names/contact information of three references. Please reference Job Code: OTAT-21-04-ASH.

Contact Information

CBER Recruitment
10903 New Hampshire Ave
Silver Spring, MD 20993 USA
cber.employment@fda.hhs.gov

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