Director, PET Drug Evaluation in United States of America

Description

PROGRAM DESCRIPTION

The Frederick National Laboratory for Cancer Research (FNL) is a Federally Funded Research and Development Center sponsored by the National Cancer Institute (NCI) and operated by the prime contractor Leidos Biomedical Research, Inc. FNL is responsible for pursuing a unique mission in translational and applied biomedical research that is unsuitable for academia, the pharmaceutical industry, or other federal contractors. 

The selected candidate will join the NCI Division of Cancer Treatment and Diagnosis (DCTD) support group located at the NCI-Frederick campus. This program supports the NCI DCTD by developing and providing radiopharmaceuticals for clinical trials and preclinical studies. Activities include production and/or procurement of investigational and experimental radiopharmaceuticals; contributing to the advanced development of the DCTD- and non-DCTD-sponsored investigational radiopharmaceuticals; supporting clinical trials; and providing nuclear medicine sites with access to DCTD radiopharmaceuticals.

The ideal candidate is an experienced chemist who enjoys working on multiple high-impact projects in both the developmental and cGMP-compliant manufacturing arenas and is highly motivated to contribute to the fight against cancer.

• Manage the acquisition of investigational PET imaging agents and their timely delivery to NIH/NCI clinical trial sites from contractors from throughout the U.S. 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 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.

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a PhD degree in chemistry, radiochemistry, physics, radiation biology, biology, engineering, or related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) or eight (8) years of related experience.  Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of eight (8) years of experience with development of investigational radioactive imaging agents.
• In addition to the education requirement, a minimum of eight (8) 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.

Candidates with these desired skills will be given preferential consideration:

• 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 working with radioactive material and requires to become an approved radiation worker.