Senior Clinical Trial Physician

Senior Clinical Trial Physician

Miltenyi Biotec

Bergisch Gladbach, Germany

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.

Qualifications

As a Senior Clinical Trial Physician, you ideally hold a medical degree (MD) with valid license to practice; board certification in hemato-oncology is strongly preferred.

• You bring a strong medical and scientific background in hemato-oncology, with proven experience in clinical trial design, execution, and supervision;
• You have experience with regulatory submissions (MAA/BLA) and scientific publications;
• You have industry experience in Pharma/Biotech, ideally in a cross-functional, global clinical development setting;
• You are highly organized, detail-oriented, and proactive, with the ability to take ownership and make decisions in a fast-paced environment;
• You are an excellent communicator and collaborator, able to work effectively with Clinical Operations, Regulatory, Biostatistics, KOLs, and other stakeholders;
• You are committed to patient safety, regulatory compliance, and scientific integrity in all aspects of your work.