Jobbeschreibung
Pentixapharm AG is a research-focused radiopharmaceutical and precision oncology company with operations focused on the preclinical, clinical development and manufacturing of the innovative theranostic drug peptide pair PentixaFor / PentixaTher and antibody-based pipeline. The clinical stage drugs specifically target the CXCR4 receptor, which is present in many rapidly progressing diseases, including hematologic and solid cancers, as well as cardiovascular diseases.
Medical Director (Global Clinical Development) (m/f/d)
Job Overview
The Medical Director / CMO will hold overall medical and clinical strategy responsibility for late-stage development programs, with a strong focus on diagnostic imaging and radiopharmaceutical development. The role combines strategic leadership with hands-on execution across pivotal clinical trials, regulatory interactions, and benefit-risk assessment in a small, highly matrixed organization.
- Overall medical and clinical strategy leadership for late-stage (Phase 2/3 and Phase 3 pivotal) development programs
- Medical leadership of clinical trial design and execution, including diagnostic and therapeutic radiopharmaceutical studies
- Primary author and senior reviewer of clinical protocols, SAP-relevant sections, Clinical IND sections, and Clinical Study Reports (CSRs)
- Oversight of benefit-risk assessment and clinical interpretation of diagnostic and imaging performance data
- Active leadership of FDA and EMA interactions, including preparation of scientific advice packages, briefing documents, and regulatory responses
- Close collaboration with regulatory affairs, clinical operations, biostatistics, translational research, and external partners
- Provide medical input to development strategy, study endpoints, and go/no-go decisions
- Operate effectively in a small, agile, highly matrixed environment, balancing strategic oversight with operational detail
- Support internal decision-making with clear, evidence-based medical and clinical insights
- MD (or equivalent medical degree); Radio/Nuclear Medicine or diagnostic imaging background strongly preferred
- Substantial experience in diagnostic imaging, ideally including PET/CT and molecular imaging
- Proven hands-on experience leading late-stage oncology or diagnostic development programs
- Strong understanding of clinical trial methodology, regulatory expectations, and data interpretation for registrational programs
- Demonstrated track record of direct engagement with FDA and EMA
- Ability to combine high-level strategic leadership with hands-on execution
- Comfortable working in a fast-paced, resource-lean biotech environment
- Fluency in English; German proficiency is a plus
Meaningful mission: Develop innovative radiopharmaceuticals that improve patients' lives
Impactful work: High responsibility in a dynamic, science-driven environment
Flexibility: Flexible hours and partial hybrid work (offices in Berlin, Würzburg, New York)
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