About the job
As a Senior Clinical Trial Physician at Miltenyi Biomedicine, you will be instrumental in leading medical and scientific initiatives to ensure the effective planning, execution, and oversight of clinical trials focused on hemato-oncology. Your role will encompass contributions to study design, regulatory submissions, data analysis, and the development of publications, while fostering collaboration with multidisciplinary teams to uphold the highest standards of patient safety and regulatory adherence.
As an esteemed member of our Medical Science team, your responsibilities will include:
- Leading the design and execution of clinical trial protocols, ensuring compliance with ICH-GCP guidelines, ethical standards, and regulatory requirements.
- Providing medical oversight for ongoing trials, partnering closely with Clinical Operations and vendor Medical Monitors, and facilitating necessary protocol amendments.
- Reviewing and interpreting clinical trial data, aiding in the preparation of Clinical Study Reports (CSRs), MAA/BLA submissions, and other regulatory documentation.
- Contributing to the creation of scientific publications and presentations, acting as a medical and scientific liaison to both internal and external stakeholders, including Key Opinion Leaders (KOLs).
- Ensuring compliance with regulatory standards, offering medical guidance on safety, adverse events, and study procedures, and assisting in the compilation of regulatory submission packages.
- Collaborating with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and external partners, to guarantee seamless execution of clinical programs while promoting a culture of scientific excellence and accountability.