Clinical Scientist

Pentixapharm AG; Deutschland; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Pentixapharm AG, together with its U.S. subsidiary Pentixapharm Inc., is a research-driven radiopharmaceutical and precision oncology company focused on the development and manufacturing of theranostic agents.

The Clinical Scientist will own the full lifecycle of radiopharmaceutical trials and support study-specific requirements across investigator sites. The role involves protocol development, data review, regulatory submissions, and collaboration with Regulatory Affairs, Biostatistics and

Qualifications

• Master's degree or PhD in Life Sciences, Pharmacy, Medicine, or a related field (e.g. Biochemistry, Biology, Pharmacology, Nuclear Medicine)
• At least 5 years of hands-on industry experience in clinical development or clinical operations within pharma or biotech
• Experience in radiopharmaceuticals and/or nuclear medicine; PET/CT and molecular imaging experience strongly preferred; oncology or hematology background is a plus
• Solid understanding of clinical trial methodology, GCP, ICH guidelines, and regulatory expectations for registrational programs; proven ability to author clinical documents independently
• Self‑driven, structured, and detail‑oriented with strong scientific writing, analytical and presentation skills; fluency in English required, German a plus

Responsibilities

• Support and independently execute Phase 1-3 radiopharmaceutical and oncology clinical trials including protocol development, site initiation support, scientific oversight of study conduct, and ensuring GCP compliance in close collaboration with Clinical Operations and CROs
• Serve as day-to-day scientific / clinical contact for investigator sites, CROs, and external partners
• Contribute to and author clinical study protocols, protocol amendments, investigator brochure updates, Clinical Study Reports (CSRs), and regulatory submission documents
• In-depth research of clinical and science topics to enable evidence and data-based decision-making to design trials and analyse clinical data
• Support preparation of scientific advice packages, briefing documents, and responses to health authority queries; contribute to benefit-risk assessments and go/no-go discussions
• Review and interpret clinical data with focus on diagnostic imaging, PET/CT results, and molecular imaging endpoints; collaborate with biostatistics on data analysis plans and SAP-relevant sections
• Continuously review and interpret emerging scientific and clinical literature across relevant disease areas and imaging modalities. Translate key findings into actionable insights for clinical development, including potential implications for study design, endpoint strategy, and data interpretation
• Collaborate closely with regulatory affairs, biostatistics, translational research, manufacturing, and external partners; contribute to scientific congresses and present study progress to internal and external stakeholders

Skills

Clinical development

Scientific writing

Data analysis

GCP/ICH knowledge

English fluency

German language

Education

Master's or PhD in Life Sciences

Job description

Pentixapharm AG, together with its U.S. subsidiary Pentixapharm Inc., is a research-driven radiopharmaceutical and precision oncology company focused on the preclinical and clinical development, as well as manufacturing, of innovative theranostic agents. Its lead drug candidate pair, PentixaFor/PentixaTher, along with an antibody-based pipeline, targets the CXCR4 receptor. Target indications include hematologic and solid cancers, as well as cardiovascular and endocrine disorders.

Our vision is to expand the boundaries of radiopharmaceuticals.

Job Overview

The Clinical Scientist will be an integral part of our Clinical Development & Operations team, taking independent scientific ownership across the full lifecycle of our radiopharmaceutical trials, from protocol development through data review and regulatory submissions. The role will also include scientific site management support to ensure high-quality execution of imaging procedures and consistent implementation of study-specific requirements across investigator sites. The clinical scientist will conduct in-depth literature, data and expert research to support key decision-making in the clinical program. Working closely with cross-functional colleagues, the Clinical Scientist will contribute directly to advancing PentixaFor/PentixaTher and our broader pipeline toward registration.

Your Tasks

• Support and independently execute Phase 1-3 radiopharmaceutical and oncology clinical trials including protocol development, site initiation support, scientific oversight of study conduct, and ensuring GCP compliance in close collaboration with Clinical Operations and CROs
• Serve as day-to-day scientific / clinical contact for investigator sites, CROs, and external partners
• Contribute to and author clinical study protocols, protocol amendments, investigator brochure updates, Clinical Study Reports (CSRs), and regulatory submission documents
• In-depth research of clinical and science topics to enable evidence and data-based decision-making to design trials and analyse clinical data
• Support preparation of scientific advice packages, briefing documents, and responses to health authority queries; contribute to benefit-risk assessments and go/no-go discussions
• Review and interpret clinical data with focus on diagnostic imaging, PET/CT results, and molecular imaging endpoints; collaborate with biostatistics on data analysis plans and SAP-relevant sections
• Continuously review and interpret emerging scientific and clinical literature across relevant disease areas and imaging modalities. Translate key findings into actionable insights for clinical development, including potential implications for study design, endpoint strategy, and data interpretation
• Collaborate closely with regulatory affairs, biostatistics, translational research, manufacturing, and external partners; contribute to scientific congresses and present study progress to internal and external stakeholders

Experience & Skills

• Master's degree or PhD in Life Sciences, Pharmacy, Medicine, or a related field (e.g. Biochemistry, Biology, Pharmacology, Nuclear Medicine)
• At least 5 years of hands‑on industry experience in clinical development or clinical operations within pharma or biotech
• Demonstrated experience in radiopharmaceuticals and/or nuclear medicine; PET/CT and molecular imaging experience strongly preferred; oncology or hematology background is a plus
• Solid understanding of clinical trial methodology, GCP, ICH guidelines, and regulatory expectations for registrational programs; proven ability to author clinical documents independently
• Self‑driven, structured, and detail‑oriented with strong scientific writing, analytical and presentation skills; comfortable in a fast‑paced, resource‑lean, matrixed environment; fluency in English required, German a plus

What We Offer

• 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 (location options: Berlin, Würzburg, New York).

With us, ideas turn into action!

Thanks to our flat hierarchies and innovation‑oriented company culture, you'll have the opportunity to truly make an impact. We take pride in our collaborative work environment, built on mutual respect, appreciation, and a wide variety of engaging, meaningful tasks.