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National Clinical Laboratory Network Pharmacodynamic Assay Operations Manager

Employer
Frederick National Laboratory for Cancer Research
Location
Frederick, MD, USA
Start date
Apr 5, 2019

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Discipline
Clinical, Clinical Research, Science/R&D, Laboratory
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
BioCapital
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Job Details

The Clinical Pharmacodynamic Program (CPP) is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program (DTP) and the Experimental Therapeutics Clinical Trials Network (ETCTN) of the National Cancer Institute (NCI). The scope of work is broad and includes assay design, development, validation, fitness for purpose testing, transfer and support of assays in internal and external clinical laboratories, and clinical specimen analysis when required. The CPP has recently been tasked with supporting a National Clinical Laboratory Network (NCLN) for Precision Oncology by establishing, participating in, leading and assuring the quality of a national network for clinical laboratories capable of providing robust and relevant clinical assays that are harmonized across laboratories. The NCLN will provide complete assay services covering all aspects of molecular characterization, diagnostic protein assays and pharmacodynamic assays of patient samples in support of the ETCTN.

KEY ROLES/RESPONSIBILITIES

The NCLN PD Assay Operations Manager, will:
  • Oversee conduct of preclinical and clinical pharmacodynamic assay support within established NCLN PD laboratories
  • Support the transfer of additional pharmacodynamic assays to established network laboratories
  • Support the establishment of additional assay support tasks at established laboratories and the establishment of additional network laboratories as required
  • Participate in the CPP ETCTN clinical trial protocol LOI review process and subsequent required coordination NCLN PD support with clinical trial sites, biospecimen repository and PD network laboratories for new clinical trial protocols
  • Oversee the data management infrastructure and data reporting process for the PD network laboratories including raw and analyzed assay data and associated records, immunofluorescent assay images, Medidata RAVE Case Report forms and web reporting tools, and coordination of the transfer of final, published data sets to the NCI Cancer Research Data Commons
  • Track the NCLN PD clinical trial support sample accrual commitments, actual accrual numbers and associated data reporting metrics
  • Provide regular status updates to CPP and NCI leadership, ET-CTN investigators and other stakeholders

BASIC QUALIFICATIONS
  • Possession of a PhD degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to Operations Management, Industrial Engineering, Systems Engineering or Biomedical Research. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to educational requirements, at least two (2) years of experience, in a field related to Scientific Operations Management
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Basic knowledge of protein biomarkers, biochemistry, pharmacology and/or immunology
  • Basic knowledge of immunoassay formats and platforms such as Luminex, slide-based Immunofluorescence assays, flow cytometry, and RT-qPCR and circulating tumor cell platforms
  • Basic knowledge of digital pathology software systems, such as Aperio eSlide Manager, Indica Labs HALO or similar
  • Basic knowledge of Medidata Rave or similar EDC system
  • Experience with scientific writing of manuscripts, standard operating procedures and/or laboratory manuals
  • Working knowledge of database concepts
  • Proficiency in MS Office suite, especially Microsoft Excel

Expected Competencies:
  • Organized, detail oriented professional with strong work ethic and ability to effectively multitask
  • Outstanding English language communication skills are required, both spoken and written
  • Ability to effectively communicate with program leads and support staff in a demanding scientific environment
  • Ability to work well in a diverse team setting


Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

Company

A rewarding career with global impact

Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.

Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.

We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.

Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.

Discover why joining the Frederick National Laboratory team could be the most important career step you take

 

 

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Company info
Website
Phone
301-846-1000
Location
8560 Progress Drive
 Frederick
MD
21701
US
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