Medical Affairs Scientist II (MD Required) - Remote
Frederick National Laboratory • November 18
Medical Affairs Scientist II (MD Required) - Remote
Job ID: req3049
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.
The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Microbiology (DMID) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. In support of the Antiviral Program for Pandemics (APP) and other collaborations, NIAID/DMID has requested Leidos Biomed provide research support services to foster the development of safe and effective antivirals to combat SARS-CoV-2, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential.
KEY ROLES/RESPONSIBILITIES
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork
Job ID: req3049
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.
The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Microbiology (DMID) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. In support of the Antiviral Program for Pandemics (APP) and other collaborations, NIAID/DMID has requested Leidos Biomed provide research support services to foster the development of safe and effective antivirals to combat SARS-CoV-2, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential.
KEY ROLES/RESPONSIBILITIES
- Designs and executes clinical studies
- Provides scientific expertise and guidance in support of research needs
- Provides insight into the pathophysiology of disease processes to facilitate development of medical countermeasures and treatment options
- Provides clinical perspective to inform, design, and interpret sub-studies
- Interprets research data for the protocol team
- Collaborates in the establishment and management of clinical trials infrastructure to support Phase I-III clinical research protocols in emerging infectious diseases
- Works collaboratively to prepare abstracts and publications of study results
- Contributes to progress reporting and contract deliverables representing study data and metrics
- May supervise staff
- This position is 100% Telework
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a Doctoral degree (M.D.) from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) appropriate to biomedical research
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirements, a minimum of two (2) years of post-graduate experience
- Experience in Phase I clinical research medical affairs
- Ability to develop, direct, manage and evaluate strategic plans, programs, communications, and activities in the context of clinical research
- Knowledge of clinical research concepts, principals, methodology and techniques
- Ability to develop and effectively deliver oral presentations and written materials for a variety of audiences and multiple venues
- Ability to make administrative and procedural decisions
- Ability to work effectively with a wide range of constituencies in a diverse community, domestically and internationally
- Knowledge of current and emerging communications and trends in infectious disease clinical research
- Ability to supervise and train assigned staff including organizing, prioritizing and scheduling work assignments
- Ability to travel to domestically/internationally up to 10%
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Seven (7) years of post-graduate experience, including five (5) years at a Senior Scientist level
- Familiarity with management of study products and supplies
- Experience conducting federally funded research studies
- Clinical research with infectious disease experience
- Experience with reviewing data for safety signals
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork