Director, PET Drug Evaluation
Job ID: req1357
Employee Type: exempt full-time
Facility: Rockville: 9609 MedCtrDr
Location: 9609 Medical Center Dr, Rockville, MD 20850 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.
Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.
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
- 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.
- 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
- Ability to obtain and maintain a security clearance
- 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
- 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)