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Cambridge, Massachusetts, United States
Onsite
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.
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.
Advanced degree (MSc, PhD or MD) in medical physics, nuclear medicine physics, biomedical engineering, radiochemistry or a closely related discipline. An equivalent clinical qualification (nuclear medicine physician, certified medical physicist or senior nuclear medicine technologist) with commensurate clinical trial experience will also be considered.
Minimum 5 years of relevant industry experience for appointment at Associate Director; 8 or more years for appointment at Director.
Direct experience designing and managing imaging aspects of clinical protocols for oncology radiopharmaceutical agents, including study design, endpoint selection, dosimetry, harmonisation between clinical sites and imaging core lab oversight.
Specific experience with imaging study design and direct or indirect estimation of normal organ and tumour dosimetry for early-stage clinical development of RLT agents.
Demonstrated expertise in quantitative SPECT/CT and PET/CT in a clinical setting.
Working knowledge of internal dosimetry principles.
Experience authoring imaging charters and site imaging manuals to regulatory standards
Experience selecting and governing imaging CROs, core laboratories or dosimetry vendors.
Fluency in oncology response assessment, including RECIST 1.1, PCWG and molecular imaging response frameworks.
Experience contributing imaging or dosimetry content to IND/CTA submissions and responses to health authority questions.
Preferred
Direct experience with 212Pb, or with other alpha emitters.
Experience with elementally matched imaging surrogates for treatment planning, including 203Pb.
Prostate cancer experience, and familiarity with PSMA PET tracers and response criteria.
First-in-human and dose-escalation experience.
Prior experience at an imaging CRO or imaging core laboratory.
Personal Attributes
Proactive, detail-oriented, and eager to learn.
Comfortable working in a fast-paced biotech environment; hands-on and self-directed.
Team player who thrives on collaboration and cross-functional flexibility.
Demonstrated ability to work well under pressure, both independently and as part of a team.
Strong organisational, planning, and time management skills.
Commitment to safety, continuous improvement, and staying current with industry trends and advances.
What We Offer
A unique chance to contribute to first-in-class cancer therapies.
Exposure to both imaging and clinical development in a dynamic biotech setting.
Hands-on training and professional development opportunities.
An international, collaborative, and supportive work culture.
Competitive compensation and benefits.
