Actithera

The Global Regulatory Head directs the regulatory strategy and submissions for the RLT portfolio, ensuring compliance with international standards for radiopharmaceuticals. This role owns critical documents like briefing books, IND/CTAs, and overall regulatory planning to achieve timely approvals.

This senior leadership role is responsible for overseeing the clinical development strategy and execution for the company's flagship radiopharmaceutical ligand therapy (RLT) asset, driving scientific and strategic initiatives from early development through regulatory approval. Key duties include leading protocol design, defining the Target Product Profile, managing Key Opinion Leader engagement, and overseeing scientific documentation.

The Head of Clinical Science is responsible for generating and interpreting clinical data for the company's RLT portfolio, ensuring the scientific integrity of clinical documents. Key tasks include writing investigator brochures, statistical analysis plans, and clinical study reports, while collaborating with cross-functional teams.