Lead Clinical Scientist - Drug Development

Lead Clinical Scientist - Drug Development

Miltenyi Biotec

Bergisch Gladbach, Germany

Job Description

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, oncology, with a focus on advanced therapy medicinal products (ATMPs), including cell and gene therapies. 

• In this role, you contribute to the development and execution of global clinical development plans (Phases I–III), ensuring scientific excellence and regulatory alignment;
• Additionally, the design, drafting, and review of clinical trial protocols, amendments, and study-related documents fall within your scope of responsibility;
• A key focus lies in ensuring the generation of high-quality clinical data and supporting the preparation of regulatory submissions (e.g., IND, CTA, BLA, MAA);
• Close collaboration with cross-functional teams; including medical, regulatory, biometrics, operations, CMC, and safety; is essential, as is representing Clinical Development in internal and external settings;
• Next to this, you support the professional development of junior scientists and contribute to establishing team-wide standards, processes, and best practices. 

Qualifications

• You hold an advanced degree (PhD, MD, PharmD, 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 advanced therapy medicinal products (ATMPs) and/or CAR-T therapies;
• You have a proven track record in protocol development, regulatory submissions (IND, CTA, BLA, MAA), and clinical data interpretation, and are recognized as an expert in the end-to-end process of clinical data generation, from protocol design through to final reporting;
• You demonstrate 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;
• You 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;
• As an integral team member of Clinical Drug Development, you communicate complex scientific data clearly and effectively in English, both in writing and speaking, and leadership by coaching, mentoring, and educating less experienced colleagues while upholding high scientific and operational standards.