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Biotech • Pharmaceutical
Leads global regulatory strategy for clinical-stage radiopharmaceutical programs, including IND, CTA, and DMF submissions; manages FDA and international health authority interactions; ensures compliance across clinical development and manufacturing; identifies and mitigates regulatory risks; advises executives; and builds regulatory capabilities through team leadership, mentoring, and cross-functional collaboration.
Biotech • Pharmaceutical
Lead clinical imaging and dosimetry strategy for radioligand therapy trials. Responsibilities include designing imaging protocols, establishing quantitative SPECT/CT and PET/CT standards, overseeing dosimetry, authoring regulatory and trial documents, qualifying sites, managing imaging CROs and vendors, training study teams, supporting health authority interactions, and contributing to scientific publications and presentations. The role requires advanced expertise in oncology radiopharmaceutical development, internal dosimetry, imaging harmonization, and response assessment.
