Associate Principal Scientist supporting regulatory strategies for Vaccine & Infectious Disease products. Collaborating globally and assisting submissions for regulatory compliance in the pharmaceutical industry.
About the role
- Seeking a Translational PET Imaging Scientist to lead clinical implementation of novel PET tracers for oncology trials. Ensuring efficient translation and guiding regulatory submissions within multidisciplinary teams.
Responsibilities
- Develop and lead the clinical imaging strategy for application of novel PET tracers in early clinical oncology trials.
- Design, oversee, and interpret PET imaging studies in animal models and early-phase clinical trials (Phase I).
- Familiarity with regulatory and quality frameworks applicable to radiopharmaceuticals.
- Prepare and contribute PET-specific scientific content for regulatory filings.
- Coordinate with CROs, CDMOs, and clinical sites to support cGMP manufacturing logistics.
- Serve as the PET imaging subject-matter expert on project teams.
- Interpret imaging data, author study reports, and present findings internally and externally.
Requirements
- Ph.D. or equivalent doctorate degree in Biomedical/Imaging Science, Radiochemistry, Physics, Pharmacology or a related field and seven (7) years of relevant experience.
- Demonstrated experience advancing novel PET tracers into clinical studies.
- Experience as imaging lead on Phase I oncology trials.
- Strong understanding of radiopharmaceutical development, radiochemistry, and quality control.
- First-hand experience with regulatory pathways and requirements for novel PET tracers in early-phase clinical trials.
- Excellent written and verbal communication skills.
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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