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Senior clinical trial physician (m|f|d)

Bergisch Gladbach
Miltenyi Biomedicine
Inserat online seit: 13 Januar
Beschreibung

Job Description As a Senior Clinical Trial Physician, you will play a pivotal role in providing medical leadership and scientific expertise to ensure the successful planning, execution, and supervision of clinical trials in hemato-oncology. You will contribute to study design, regulatory submissions, data review, and publications, while collaborating closely with cross-functional teams to maintain the highest standards of patient safety and regulatory compliance. As a valuable member of the Medical Science team: You will lead the design and implementation of clinical trial protocols, ensuring adherence to ICH-GCP, ethical standards, and regulatory requirements. You will provide medical supervision of ongoing trials, working closely with Clinical Operations and vendor Medical Monitors, and support protocol amendments as needed. You will review and analyze clinical trial data, contributing to Clinical Study Reports (CSRs), MAA/BLA submissions, and other regulatory documentation. Next to this, you will support the development of scientific publications and presentations, serving as a medical and scientific interface to internal and external stakeholders, including KOLs. You will ensure regulatory compliance, providing medical guidance on safety, adverse events, and study conduct, and contributing to the preparation of regulatory submission packages. In addition, you will work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and external partners, to ensure the smooth execution of clinical programs and foster a culture of scientific excellence and accountability.

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