Medical Director; Global Clinical Development

Medical Director (Global Clinical Development) (m/f/d) About Us

Pentixapharm AG is a research-driven radiopharmaceutical and precision oncology company focused on developing innovative theranostic therapies. Our clinical-stage programs target the CXCR4 receptor, which plays a key role in aggressive hematologic and solid tumors as well as cardiovascular diseases. We operate in a lean, science-driven biotech environment with a strong focus on execution and accountability.

We are looking for an experienced Medical Director (Global Clinical Development) to lead the overall medical and clinical strategy for our late-stage development programs, with a strong focus on diagnostic imaging and radiopharmaceutical development.

This role combines strategic leadership with hands‑on execution across pivotal clinical trials, regulatory interactions, and benefit–risk assessment in a highly matrixed biotech environment.

• Lead overall medical and clinical strategy for late-stage (Phase 2/3 and Phase 3 pivotal) development programs
• Provide medical leadership for clinical trial design and execution, including diagnostic and therapeutic radiopharmaceutical studies
• Author and review clinical protocols, Clinical IND sections, SAP‑relevant sections, and Clinical Study Reports (CSRs)
• Oversee benefit–risk assessment and interpretation of diagnostic and imaging performance data
• Lead interactions with FDA and EMA, including preparation of briefing books and regulatory responses
• Collaborate closely with Regulatory Affairs, Clinical Operations, Biostatistics, Translational Research, and external partners
• Provide medical input to development strategy, endpoints, and go/no-go decisions

• MD (or equivalent medical degree); background in Radio/Nuclear Medicine or diagnostic imaging strongly preferred
• Substantial experience in diagnostic imaging, ideally including PET/CT and molecular imaging
• Proven experience leading late-stage oncology or diagnostic development programs
• Strong understanding of clinical trial methodology, regulatory expectations, and registrational strategy
• Demonstrated direct engagement with FDA and EMA
• Ability to combine high-level strategic thinking with hands‑on execution
• Comfortable working in a lean biotech environment with high accountability
• Fluency in English;
  German is a plus

• High-impact leadership role with strategic ownership of late-stage global programs
• Science-driven, collaborative biotech culture with flat hierarchies
• Flexible, hybrid working model (Europe or US East Coast)