FDA/Center for Biologics Evaluation and Research
Silver Spring, MD, USA
$250,000 - $299,999
December 1, 2020
December 1, 2020-April 30, 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 a Supervisory Physician overseeing OTAT regulated products for hematologic conditions.
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.
Responsibilities: As a Supervisory Physician overseeing hematologic conditions, duties may include but are not limit to:
• Ensuring the safety and effectiveness of biological therapies and devices used in the prevention, treatment, cure and mitigation of disease for hematologic conditions.
• Supervising the review and evaluation of clinical protocols and other clinical information related to regulatory submissions, such as Investigational New Drug (INDs) applications and Investigational Device Exemptions (IDEs), marketing applications and communications with sponsors and applicants.
• Assisting the DCEPT Division and Deputy Division Director in policy development applicable to clinical review and evaluation of products regulated by OTAT.
• Serves as a Center and Agency authority providing advice on clinical issues regarding development of biological therapies or devices regulated by OTAT.
• Represents the Center, FDA, Public Health Service, and Department of Health and Human Services on committees or at scientific/professional meetings with both national and international groups and organizations.
•Provides executive leadership and direction to a professional staff graded through to GS-15 or GP-15.
•Directs the clinical review of marketing applications for biological therapies and medical devices regulated by OTAT, based on application of policy and standards to the safety and effectiveness of the therapies.
•Directs and encourages training for CBER reviewers in clinical trial design and analysis.
•Provides staff leadership and direction and advises the Division, Office, and Center Directors in all matters related to the planning, development, formulation, implementation, execution, administration and coordination of activities which affect policies, programs and goals involving the safety and effectiveness of biological therapies intended for human use.
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;
•Experience in the design, conduct, and interpretation of clinical trials;
•Experience in effectively managing large 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: 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.
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 firstname.lastname@example.org and carbon-copy Tejashri Purohit-Sheth at email@example.com. Supporting documentation may include: bibliography, summary of research accomplishments, and names/contact information of three references. Please reference Job Code: OTAT-21-03-ASH.
10903 New Hampshire Ave
Silver Spring, MD 20993 USA
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