NVision is a quantum medtech startup based in Ulm, Germany, backed by top-tier investors from Silicon Valley and Europe. Having left stealth mode, we are entering an exciting new phase - shifting from R&D toward global commercialization with our own clinical development and go-to-market programs.   

Our proprietary hyperpolarization technology enables real-time metabolic imaging using standard MRI scanners. By enhancing the MRI signal of key biomolecules, we provide unprecedented metabolic insights that can improve risk stratification, guide treatment decisions, and enable clinicians to assess therapeutic response early - well before anatomical changes are visible. Current applications of this technology include oncology, cardiology, neurology, metabolic diseases and more.

Central to our approach is a fully automated platform that produces injectable hyperpolarized contrast agents in under three minutes. Designed for clinical use, our compact polarizers can be placed directly at the point of care.

At NVision, we unite experts across physics, chemistry, engineering, and medicine, and collaborate with leading institutions such as Memorial Sloan Kettering Cancer Center, MD Anderson, Cambridge University, and the Technical University of Munich. As we advance into clinical translation, we are building a strong internal clinical team to shape the future of precision diagnostics.

JOB DESCRIPTION

We are seeking an experienced Head of Clinical Development (m/f/d). In this position, you will be instrumental in leading clinical trial strategies for NVision's hyperpolarized MRI agents, managing clinical trials from study design to execution. You will collaborate with leading academic centers and build capabilities at NVision. This role is crucial in driving the clinical translation of our cutting-edge technology.

Responsibilities:

• Development of clinical trial strategies and study design: 

  • Design and implement comprehensive clinical trial strategies aligned with the company's overall business objectives and target indications, leveraging existing clinical data generated from academic research on similar available clinical platforms.

  • Work with Product Management and Regulatory Affairs to identify optimized clinical and regulatory pathways for NVision's hyperpolarized MRI technology.

  • Manage the study design and the overall planning of NVision-sponsored clinical trials, prioritizing opportunities to utilize existing academic capabilities.

• Clinical Trial Management: 

  • Lead the management of clinical trials, ensuring adherence to cGCPs, regulatory requirements, and ethical standards, while actively engaging with academic collaborators. 

  • Monitor trial progress and analysis of results, identify potential issues, and implement corrective actions.

  • Manage clinical trial budgets and adherence to timelines and trial plans

  • Oversee the selection and management of clinical research organizations (CROs) and other vendors.

  • Lead the development of systems and processes in support of NVision clinical activities as part of the NVision Quality Management System. 

• Regulatory and medical affairs: 

  • Collaborate with Regulatory Affairs to prepare and submit regulatory filings, including regulatory meetings, INDs, IMPDs, and other necessary documentation.

  • Provide medical scientific support to internal and external stakeholders.

  • Contribute to the development of scientific publications and presentations, support the company at conferences and marketing events.

• Team Leadership: 

  • Build and lead a clinical trial team adapted to the needs and strategy of the company.