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 market and ensuring the safety of our pharmacological developments at all stages.
Job Description
As Group Leader – Clinical Operational Excellence, you will lead a team of experts and take ownership of driving operational excellence across our European Clinical Development organization. In this strategic role:
1. You will lead and coordinate clinical operational excellence initiatives including inspection readiness initiatives across Clinical Development EU, ensuring compliance with GCP, SOPs, and regulatory requirements while driving efficiency and high-quality standards.
2. Together with your team you will oversee TMF services, trial oversight- and training requirements for clinical studies, including Key Peformance Indicator management, TMF vendor oversight, and proactive risk mitigation.
3. In addition, you will drive innovative approaches with focus on clinical trial oversight-, TMF-, and trial training strategy and ensure best‑practice implementation.
4. Next to this together with your team, you will identify and implement process improvements, lead cross-functional initiatives to standardize clinical operations, and ensure proper Training Coordination to maintain accurate training records.
5. You will support the ClinDev EU team with audits and regulatory inspections by preparing documentation, tracking CAPAs, and reviewing trial-related manuals and plans to communicate quality requirements.
6. In this leadership position, you will collaborate closely with Clinical Trial Management, Data Management, QA, and vendors, providing structured leadership through goal setting, coaching, and performance reviews.
7. Finally, you develop effective relationships with internal and external stakeholders and work in a dynamic environment to continuously improve operational processes and compliance standards.
Qualifications
8. You hold a university degree in Life Sciences, Natural Sciences, or a related healthcare field and bring proven experience in clinical operations within the pharmaceutical or biotech industry.
9. You have a strong track record in sponsor oversight for Phase II/III trials and hands-on TMF (eTMF) management, with measurable improvements in quality, completeness, and timeliness.
10. You possess in-depth knowledge of ICH E6(R2/R3), EU CTR, EMA/FDA inspection behaviors, SOP governance, and trial-specific oversight plans, and you are skilled at prioritizing multiple tasks to meet timelines.
11. You are a strong and experienced leader with proven disciplinary and functional management skills, demonstrating excellent organizational abilities and fostering collaboration across clinical teams and vendors.
12. You communicate effectively in English (German is a plus), enjoy working in a dynamic environment, and demonstrate pragmatic, risk-based decision-making with a solution-oriented mindset.
13. You are a motivated and open-minded team player with strong interpersonal skills and the ability to thrive in complex, fast-paced settings.
Additional Information
What we offer
14. Working with free and self-determined time management, also mobile working
15. An intercultural environment characterized by diversity and flat hierarchies
16. Freedom to contribute creatively and play an active role in shaping the company
17. Individual further training in our Miltenyi University as the core of the Miltenyi DNA
18. 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.