Teams at Actithera, Inc.

Senior leader responsible for clinical development strategy and execution for a radiopharmaceutical ligand therapy asset. Oversees protocol design, TPP, KOL engagement, investigator brochures, regulatory input (IND/CTA), scientific communications, cross-functional alignment, risk mitigation, and team mentorship to advance trials through approval and commercialization.

Lead clinical science for the radioligand therapy (RLT) portfolio: author ICH-compliant IBs, SAPs, CSRs, nonclinical summaries, design scientific figures, interpret trial data, support regulatory/medical teams, and mentor clinical scientists to improve workflows.

Lead global regulatory strategy and submissions for radiopharmaceutical (RLT) portfolio. Own briefing books, IND/CTA filings and amendments, ensure ICH/GMP and radiation-specific compliance, engage health authorities (FDA, EMA, PMDA), coordinate clinical/CMC/quality teams, monitor regulatory landscape, and mentor regulatory staff to secure timely approvals.