Medical Director

Overview

We are seeking an experienced Medical Director (Oncology) to support late-stage clinical development of radiopharmaceutical programs, with a focus on Phase 3 / registrational studies. This role will provide medical leadership across pivotal trials and contribute to clinical strategy, regulatory interactions, and submission readiness.

Responsibilities

• Provide medical leadership for Phase 3 radiopharmaceutical oncology trials, ensuring high-quality execution and delivery
• Contribute to registrational strategy, including endpoint selection, dosimetry considerations, and study design
• Lead the development and review of protocols, investigator brochures, and clinical study reports
• Act as medical monitor, ensuring patient safety, radiation safety considerations, and data integrity
• Interpret clinical and safety data, including radiation-related toxicities and exposure profiles
• Support regulatory interactions and submissions (IND/NDA/BLA), including briefing documents
• Collaborate cross-functionally with clinical operations, regulatory, translational, CMC (radiochemistry), and biometrics teams
• Engage with KOLs, nuclear medicine specialists, and investigators to support study execution and program strategy

Requirements

• MD (or equivalent) with clinical training in oncology, nuclear medicine, or radiation oncology
• Strong experience in late-stage oncology clinical development (Phase 2/3)
• Experience working on or supporting radiopharmaceutical or radiation-based therapies
• Proven involvement in pivotal / registrational trials
• Understanding of dosimetry, radiation safety, and radiopharma development considerations
• Experience supporting regulatory submissions and health authority interactions
• Strong knowledge of FDA/EMA guidelines and GCP standards

Preferred

• Experience with alpha or beta-emitting radiotherapies
• Background working with nuclear medicine or radiopharma manufacturing teams
• Prior experience in biotech or clinical-stage radiopharma companies