Global Medical Director, Radiopharma & Imaging

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. The Role 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. Key Responsibilities 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 Your Profile 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 Why Join Us 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)

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