We are seeking an Associate Director / Director of Clinical Imaging who will be expected to take on a highly visible role with internal and external stakeholders through development of the strategy and management of imaging and dosimetry for clinical protocols in ARTBIO's Radioligand Therapy (RLT) clinical development programs. As a critical member of the Clinical Team, you will work closely with program leads, functional heads and subject matter experts to advance the company's development pipeline.
Responsibilities
Imaging and dosimetry strategy
Develop clinical imaging and dosimetry strategies designed to support clinical development plans for ARTBIO's RLT agents.
Design and implement imaging protocols, plans and procedures for clinical studies.
Define quantitative imaging standards across the portfolio, including acquisition and reconstruction parameters, calibration and QC frameworks, and site qualification criteria for SPECT/CT and PET/CT.
Oversight of dosimetry methodology: segmentation and registration, time-activity curve fitting, time-integrated activity estimation, and organ- and lesion-level absorbed dose calculation.
Evaluate and integrate emerging imaging methods, including surrogate-isotope approaches and automated lesion segmentation.
Trial documentation and design
Author imaging charters, site imaging manuals, data transmittal specifications and analysis plans.
Contribute imaging and dosimetry content to protocols, amendments, schedules of assessment, informed consent forms, Investigator's Brochures and clinical study reports.
Site and vendor execution
Provide oversight and guidance for all aspects of Medical Imaging for clinical trials.
Oversee site imaging feasibility, qualification and activation, including equipment surveys, phantom acceptance, test transmissions, and cross-calibration between dose calibrator and camera.
Deliver training on imaging requirements and response criteria to investigators, technologists, study teams and CRAs, and at investigator meetings.
Oversee CRO vendors including imaging core labs and dosimetry vendors.
Manage the resolution of technical, radiological and dosimetry questions and issues on a study and program level.
Regulatory, scientific and external engagement
Deliver subject matter expertise regarding advanced imaging techniques (including PET/CT, SPECT/CT, MRI, CT and other modalities as needed), image evaluation, and dosimetry estimation.
Support health authority interactions on imaging and dosimetry, including IND/CTA content and responses to agency questions.
Lead imaging and dosimetry academic collaborations, contractor and vendor/partner interactions, and build and maintain a network of external experts to inform protocol design.
Provide scientific and technical support and oversight in research activities.
Contribute to abstracts, posters, manuscripts and scientific presentations.
Qualifications & Experience Required