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

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

11 Mar, 26

Salary

0.0

Posted On

11 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development, Regulatory Submissions, Protocol Development, Clinical Data Interpretation, Biostatistics, Data Management, Medical Monitoring, Translational Insights, Biomarkers, Clinical Endpoints, Team Collaboration, Coaching, Mentoring, Scientific Communication, Operational Standards

Industry

Biotechnology Research

Description

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 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. Additional Information What we offer Working with free and self-determined time management, also 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 as the core of the Miltenyi DNA 30 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.

Responsibilities

As a Lead Clinical Scientist, you will advance innovative therapies in autoimmune diseases and oncology, focusing on advanced therapy medicinal products. You will ensure scientific excellence and regulatory alignment while collaborating with cross-functional teams.