Medical Director

About the Role

A clinical-stage oncology-based company is seeking an experienced Medical Director, Global Clinical Development to lead late-stage clinical programs. The role has a strong focus on diagnostic imaging and theranostic development, combining strategic leadership with hands-on execution in a highly matrixed biotech environment.

This is a high-impact position with direct ownership of pivotal trials, regulatory interactions, and benefit–risk strategy.

• Lead overall medical and clinical strategy for late-stage (Phase 2/3 and Phase 3 pivotal) development programs
• Provide medical leadership for diagnostic and therapeutic radiopharmaceutical clinical trials
• Act as primary author and senior reviewer of clinical protocols, IND clinical sections, SAP-relevant content, and Clinical Study Reports (CSRs)
• Oversee benefit–risk assessments and clinical interpretation of imaging and diagnostic performance data
• Lead and support FDA and EMA interactions, including scientific advice and briefing documentation
• Collaborate closely with regulatory affairs, clinical operations, biostatistics, translational research, and external partners
• Contribute to development strategy, endpoint selection, and go/no-go decisions
• Operate effectively in a small, agile, resource-lean organization, balancing strategic leadership with operational detail

• Background in Radio/Nuclear Medicine or diagnostic imaging strongly preferred
• Significant experience in diagnostic imaging, ideally including PET/CT and molecular imaging
• Proven hands-on leadership of late-stage oncology or diagnostic development programs
• Strong understanding of registrational clinical trial design and regulatory expectations
• Demonstrated experience leading FDA and EMA interactions
• Ability to combine strategic oversight with hands-on execution
• Fluent in English;
  German language skills are a plus

• Ownership of pivotal clinical development programs
• Exposure to innovative theranostic and imaging-based approaches
• High visibility role with meaningful influence on clinical and regulatory strategy
• Opportunity to work in a science-driven, collaborative biotech environment