Company Description
Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale.
Join our highly professional team in bringing new medicines to the market.
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:
1. You will lead the design and implementation of clinical trial protocols, ensuring adherence to ICH-GCP, ethical standards, and regulatory requirements.
2. You will provide medical supervision of ongoing trials, working closely with Clinical Operations and vendor Medical Monitors, and support protocol amendments as needed.
3. You will review and analyze clinical trial data, contributing to Clinical Study Reports (CSRs), MAA/BLA submissions, and other regulatory documentation.
4. 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.
5. You will ensure regulatory compliance, providing medical guidance on safety, adverse events, and study conduct, and contributing to the preparation of regulatory submission packages.
6. 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.
7. You bring a strong medical and scientific background in hemato-oncology, with proven experience in clinical trial design, execution, and supervision.
8. You have experience with regulatory submissions (MAA/BLA) and scientific publications.
9. You have industry experience in Pharma/Biotech, ideally in a cross-functional, global clinical development setting.
10. You are highly organized, detail-oriented, and proactive, with the ability to take ownership and make decisions in a fast-paced environment.
11. You are an excellent communicator and collaborator, able to work effectively with Clinical Operations, Regulatory, Biostatistics, KOLs, and other stakeholders.
12. You are committed to patient safety, regulatory compliance, and scientific integrity in all aspects of your work.
Additional Information
What we offer
13. Working with free and self-determined time management, also mobile working
14. An intercultural environment characterized by diversity and flat hierarchies
15. Freedom to contribute creatively and play an active role in shaping the company
16. Individual further training in our Miltenyi University as the core of the Miltenyi DNA
17. days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more.
Diversity is the bedrock of our creativity
Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities.
You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability.
Become part of our team and focus on pushing the borders of medicine.
We look forward to your application
If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.