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We are a leading, clinically advanced biopharmaceutical stem cell company with more than 20 years of experience at our Heidelberg, Germany site, dedicated to drug development based on ABCB5-positive (ABCB5+) mesenchymal stem cells as a platform technology.
Our focus is on the development of innovative stem cell therapies for patients suffering from severe immune- and inflammation-related diseases with high unmet medical need – particularly in the field of rare diseases. Our goal is to establish new therapeutic standards where satisfactory treatment options have not yet been available.
Our ABCB5-positive adult mesenchymal stem/stromal cells derived from the skin represent a characterized, highly purified active pharmaceutical ingredient – protected by patents and manufactured according to the highest quality standards (GMP/GfP/GLP). In certain indications, they have the potential to be a true game changer and a turning point in therapy. As a manufacturer of Advanced Therapy Medicinal Products (ATMPs) in accordance with Section 13 of the German Medicines Act (AMG), we develop and produce proprietary cell therapeutics that are currently in late-stage clinical trials that are currently in late-stage clinical trials.
More than 110 employees contribute every day to bringing innovative cell therapies into clinical practice – perhaps you will soon be one of them?
Clinical Scientist *
Aufgaben
- Perform critical scientific and statistical interpretation of clinical data, providing clear insights to support sound, evidence-based decision-making.
- Contribute to the planning, execution, and interpretation of pre-planned, exploratory, and post-hoc analyses, ensuring scientific rigor, transparency, and appropriate contextualization of results.
- Contribute to protocol and protocol amendment development, including review of eligibility criteria, endpoints, and assessments.
- Review and provide scientific input on clinical data–related documents, including statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and clinical study reports (CSRs).
- Effectively communicate clinical data and scientific conclusions, both orally and through high-quality presentations, to internal and external stakeholders.
- Support the preparation, review, and scientific alignment of regulatory and scientific documentation, such as briefing documents and responses to health authority questions. Actively contribute to clinical development strategy, including benefit–risk assessments, study optimization, interpretation of emerging data, and program-level decision-making processes.
- Provide scientific guidance on clinical study design, including definition of study objectives, endpoints, eligibility criteria, and key statistical considerations, in close collaboration with the Clinical Operations team.
- Collaborate effectively in a cross-functional, matrix environment with Clinical Operations, Biostatistics, Regulatory Affairs, Medical Writing, and external partners to ensure scientific alignment and high-quality execution.
- Support the development of abstracts, posters, and manuscripts for submission to peer-reviewed journals and scientific congresses, in collaboration with Medical Writing and Publications teams.
Profil
- Advanced degree in life sciences or a related discipline (MD, PhD, PharmD or equivalent).
- Strong expertise in clinical development, data interpretation and biostatistics with the ability to critically assess analyses, assumptions, and conclusions.
- Proven ability to interpret complex datasets and derive scientifically robust conclusions.
- Demonstrated strength in scientific communication, including clear oral presentations and the development of high-quality scientific slide decks for internal and external audiences.
- Extensive scientific writing experience, including authorship or substantial contribution to peer reviewed publications.
- Solid understanding of clinical trial methodology, Good Clinical Practice (GCP), and regulatory requirements across the clinical development lifecycle.
- Strong ability to collaborate in a cross functional, matrix organization (Clinical Operations, Biostatistics, Regulatory Affairs, Medical Writing).
- High level of scientific rigor, attention to detail, and commitment to data integrity.
- Proven capability to work independently while contributing effectively within cross functional teams.
- Excellent English communication skills, both written and verbal.
Wir bieten
- Full-time permanent position with attractive compensation
- A motivated, supportive, and collaborative team
- Opportunity to work with leading experts in clinical development, regenerative medicine, and ATMPs
- Collaborative and international working environment with strong scientific exchange
- Diverse training and professional development opportunities
- Flexible, individual mobility budget as well as free parking
- Complimentary beverages and fresh fruit for the workday
- Extensive corporate benefits
- Company pension scheme