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SENIOR CLINICIAN (MEDICAL DIRECTOR, OFFICE OF SPONSOR & REGULATORY OVERSIGHT)

Employer
Center for Cancer Research, NCI
Location
Bethesda, Maryland
Posted Date
Aug 16, 2018

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Specialty
Research
Position Type
Permanent

The Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) is seeking a Senior Clinician to oversee and sponsor regulatory activities within its clinical research portfolio. The incumbent will ensure sponsor obligations for Investigational New Drugs (IND) and Investigational Device Exemptions (IDE) are met, provide analytic support for the diverse clinical research portfolio estimated at $193 million, develop and lead a pharmacovigilance program, monitor trials, and serve as the subject matter expert regarding FDA regulations. The incumbent will supervise staff and oversee the development, standardization, implementation, and execution of policies, procedures, and standards of conduct for clinical research to ensure that all sponsored clinical research is in full compliance with all applicable regulations and policies and meets established standards of quality, integrity, and ethics.

The NCI is part of the NIH, a federal government agency. The CCR is the largest component of the intramural biomedical research effort at NIH with a large, diverse portfolio. CCR is also a major user of the NIH Clinical Center, a state-of-the-art research hospital on the campus of NIH in Bethesda, Maryland. CCR’s mission is to improve the lives of cancer patients by solving important, challenging, and neglected problems in cancer research, prevention, and patient care. CCR has an active, cutting edge clinical program carrying out clinical trials using science to create the therapies of tomorrow. The NIH Clinical Center and CCR infrastructure allow for rapid translation from the bench to bedside and back and for the conduct of high risk research, which require sustained commitment. For more information, please visit (https://ccr.cancer.gov/). 

The successful candidate must have an MD degree or clinical equivalent with extensive experience in management. Experience conducting clinical trials on human subjects is preferred. Salary is competitive and will be commensurate with the candidate’s experience. A full benefits package is available, including retirement, health insurance, life insurance, long-term care insurance, annual and sick leave, and a Thrift Savings Plan (401K equivalent). This position is subject to a background investigation and is not restricted to U.S. citizens.

Applications will be accepted September 4-13, 2018. Applications must contain CV and bibliography and must be submitted electronically to: https://irp-positions.nih.gov/job/OSRO. Please include in your CV a description of mentoring and outreach activities in which you have been involved, especially those involving women and persons from other groups which are underrepresented in the biomedical sciences. Reference contacts may be requested following an initial review of candidate applications.

The NIH is dedicated to building a diverse community in its training and employment programs.

HHS, NIH and NCI are Equal Opportunity Employers.

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