Overview:
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Responsibilities:
* Advice and review relating to radiation dosimetry and nuclear imaging on clinical trial protocols proposed by sponsors
* Design of imaging and dosimetry measures for use with diagnostic or therapeutic radionuclides
* Perform quality assurance checks on nuclear imaging and dosimetry data to ensure protocol specific requirements are met
* Scanner calibration by the analysis of phantom scans and calculation of the dosimetry conversion factor
* Image reconstruction and analysis (PET/CT, SPECT/CT and/or planar nuclear imaging)
* Dosimetry calculation (%ID/g, biological half-life, TIAC, estimated dose) in normal organ and tumor tissues using off the shelf and proprietary software
* Ensure compliance with MIRC and ICRP guidelines for radiation safety protection
* Compile and maintain project-specific status reports and project timelines associated with imaging components of clinical trials
* Perform project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols.
Qualifications:
* PhD degree in physics or in other relevant field with at least 2 years' experience in dosimetry calculation for internal radiotherapy (targeted radio nucleotide therapy)
* Or Master degree in physics or in other relevant field with at least 5 years' experience in dosimetry calculation for internal radiotherapy (targeted radio nucleotide therapy)
* Expertise in quantitative image reconstruction (nuclear medicine images)
* Expertise in internal radiotherapy and dosimetry calculation using MIRD S-values, 3D-RD and/or OLINDA/EXM 1.0 software
* Experience with internal radiation dosimetry for gamma, positron and alpha emitting radionuclides would be favored
* Experience working with clinical trials or within the pharmaceutical environment is preferred.
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