Lead Clinical Scientist – Drug Development; m|f|d

Lead Clinical Scientist – Drug Development (m|f|d)

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 accessibility worldwide. We focus on difficult‑to‑treat hematological cancers using CAR‑T and other technologies, and we explore treatments for other diseases. Our lead candidate, a tandem CAR‑T cell product, is currently undergoing pivotal clinical trials globally.

As a Lead Clinical Scientist in Clinical Drug Development, you will take on both strategic and operational responsibilities in advancing innovative therapies in autoimmune diseases and oncology, with a focus on advanced therapy medicinal products (ATMPs), including cell and gene therapies.

• Contribute to the development and execution of global clinical development plans (Phases I–III), ensuring scientific excellence and regulatory alignment.
• Design, draft, and review clinical trial protocols, amendments, and study‑related documents.
• Focus on generating high‑quality clinical data and supporting the preparation of regulatory submissions (e.g., IND, CTA, BLA, MAA).
• Collaborate closely with cross‑functional teams—including medical, regulatory, biometrics, operations, CMC, and safety—and represent Clinical Development in internal and external settings.
• Support the professional development of junior scientists and contribute to establishing team‑wide standards, processes, and best practices.

• Hold an advanced degree (PhD, MD, Pharm
  
  D, or equivalent) in life sciences, medicine, or a related field paired with significant experience in clinical development within the pharmaceutical or biotech industry, ideally including exposure to ATMPs and/or CAR‑T therapies.
• Proven track record in protocol development, regulatory submissions (IND, CTA, BLA, MAA), and clinical data interpretation, and recognized as an expert in the end‑to‑end process of clinical data generation.
• Comprehensive expertise across the clinical data lifecycle—working backwards from the desired final readouts to plan early for the necessary data, overseeing capture, coordinating cleaning and integrity checks, and obtaining study results in collaboration with biostatistics, programming, data management, and medical monitoring teams—ensuring outputs that are decision‑ready for regulatory and clinical use.
• Integrate translational insights, biomarkers, and clinical endpoints into development plans and work effectively across a matrix environment of internal stakeholders, external collaborators, and CRO partners to ensure alignment from early research through late‑stage clinical development.
• Communicate complex scientific data clearly and effectively in English, both in writing and speaking, and lead by coaching, mentoring, and educating less experienced colleagues while upholding high scientific and operational standards.

• Free and self‑determined time management, including mobile working.
• An intercultural environment characterized by diversity and flat hierarchies.
• Freedom to contribute creatively and play an active role in shaping the company.
• Individual further training in our Miltenyi University, core of the Miltenyi DNA.
• 30 days of vacation, discounted tickets to Germany, e‑bike leasing, capital‑forming benefits, company pension plan, disability insurance, canteen, and more.

Our mission is to innovate treatments and technologies and tackle the world’s most serious health challenges. 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. Come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability, we welcome you.

Seniority Level: Mid‑Senior level

Employment Type:

Full‑time

Job Function:
Other

Industries:
Pharmaceutical Manufacturing

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.