Senior Director, Clinical Dosimetry & Radiation Sciences
ExternalFull-timeOn-site2d ago
Clinical TrialsDocumentation
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Responsibilities
- How You'll Contribute
- Lead clinical dosimetry strategy across Alpha-9's radiopharmaceutical programs, defining standards for absorbed dose calculation, time-activity modeling, and interpretation across early-phase clinical studies.
- Establish and govern quantitative imaging standards for SPECT/CT and PET/CT, including acquisition protocols, reconstruction parameters, QC frameworks, and site qualification criteria.
- Serve as the internal authority on dosimetry, translating patient- and program-level dose data into actionable insights that inform dose escalation, safety evaluation, and clinical decision-making.
- Integrate dosimetry into clinical trial design and regulatory submissions, including protocols, amendments, investigator brochures, clinical study reports, and IND/CTA documentation.
- Partner closely with Clinical Development, Clinical Pharmacology, Biostatistics, and Clinical Operations to ensure dosimetry is embedded in dose selection strategy and study execution.
- Manage external imaging and dosimetry vendors and core laboratories, ensuring methodological consistency, data quality, and timely delivery across active programs.
- Support regulatory interactions and scientific communications, including responses to agencies, investigator meetings, abstracts, manuscripts, and conference presentations.
- The Skills You Bring
- PhD or MS in Medical Physics, Radiation Physics, Nuclear Medicine Physics, or related discipline (Ph.D. preferred).
- 6-10+ years of experience in radiopharmaceutical development, molecular imaging, or medical physics within oncology drug development.
- Direct experience in radiopharmaceutical or radioligand therapy clinical programs required.
- Proven experience with quantitative SPECT/CT and PET/CT imaging workflows in clinical trial settings.
- Strong understanding of internal dosimetry principles (e.g., MIRD methodology) and organ/tumor absorbed dose modeling.
- Experience contributing to or supporting IND/CTA submissions and regulatory interactions involving imaging or dosimetry.
- Demonstrated ability to translate quantitative radiopharmaceutical data into clinical development decisions.
- Experience operating in cross-functional drug development teams, ideally across multiple concurrent clinical programs.
- Experience influencing or contributing to dosimetry methodology, standards, or decision frameworks in clinical development preferred.
- Board certification (ABR or equivalent) preferred.
- Company Summary
- More about Alpha-9 Oncology
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