Frederick National Laboratory for Cancer Research

Director, PET Drug Evaluation

Location
Rockville, MD, USA
Posted
Oct 09, 2020
Ref
req1357
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time
This Frederick National Laboratory for Cancer Research (FNLCR) program supports the NCI Cancer Imaging Program (CIP) by providing investigational medical imaging agents for clinical trials primarily at the NIH/NCI Clinical Center or nearby NCI trial sites, pre-clinical evaluation of experimental medical imaging agents in patient-derived xenograft (PDX) models at FNLCR, radiochemistry operations, and regulatory affairs support. Activities include procurement of investigational and production of experimental PET imaging agents for clinical and pre-clinical studies, respectively; a timely delivery of those imaging agents to NIH/NCI conducted clinical trials in compliance with federal, state and local regulations and with institutional policies and procedures; advising on regulatory affairs supporting the life cycle of the NCI/CIP INDs required to conduct NCI-supported investigational imaging studies for radiopharmaceuticals; providing acceptable CMC sections for INDs; and contributing to development of investigational imaging agents.
KEY ROLES/RESPONSIBILITIES
  • Manage the acquisition of investigational PET imaging agents and their timely delivery to NIH/NCIclinical trial sites from contractors from throughout the US using best available strategies. This includes subcontracting with external firms specializing in the production and just-in-time delivery of these agents under the auspices of NCI/CIP INDs.
  • Monitor and evaluate the GMP compliance of external entities supplying agents under Leidos subcontracts.
  • Support the CIP IND program, by providing CMC sections for INDs used in imaging clinical studies at the NIH/NCI and other regulatory documents to the appropriate agencies for the investigational PET imaging agents provided.
  • Manage onsite laboratory development of experimental imaging agents and produce quality batches of these agents suitable for preclinical studies in mouse models of human cancer, including PDX models.
  • Ensure program activities comply with regulatory requirements.

BASIC QUALIFICATIONS
  • Possession of a Doctoral degree from an accredited college or university (according to CHEA) in chemistry, radiochemistry, physics, radiation biology, biology, engineering, or related field. Foreign degrees must be evaluated for U.S. equivalency.
  • Two (2) to five (5) years of experience with development of investigational radioactive imaging agents
  • Two (2) to five (5) years of experience with acquisition and delivery of investigational radioactive imaging agents for clinical trials
  • Working knowledge of cGMP and USP as it relates to the production of radiopharmaceuticals for human use
  • Working knowledge of cGMP and USP requirements as it relates to filing INDs with the US FDA
  • Working knowledge of NRC regulations regarding radiopharmaceuticals
  • Experience working with radioisotopes and experimental imaging agents in humans and animals
  • Background in medicinal chemistry

PREFERRED QUALIFICATIONS
  • Experience filing IND applications to the FDA and managing life cycle of INDs and related regulatory documents
  • Experience with contracting and/or outsourcing approved or investigational PET imaging agents for just-in-time delivery
  • Laboratory experience with radiochemistry to generate experimental imaging agents
  • Experience working in PET imaging agents in a pre-clinical and/or clinical setting
  • Experience developing the chemistry to create novel PET imaging agents, including targeted agents

JOB HAZARDS
  • This position is subject to working with or have potential for exposure to animal(s) and/or animal material(s)
  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • This position is subject to atmospheric conditions that would require the usage of a respirator,
    requiring a medical clearance
  • This position is subject to working with radioactive material and requires to become an approved
    radiation worker


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

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