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.

• Advanced degree (MD, PhD) in a relevant scientific or medical field.

• Strong background in clinical trial design (for phases I-III), and participation in management, with a proven track record of successfully bringing novel and innovative medical technologies from early stage clinical development to regulatory approval process.

• Strong knowledge of GCP ICH Guidelines, clinical trial regulations (EU/US), and ethical standards.

• Familiar with regulatory requirements for new drug applications in both the US and the EU.

• Experience with imaging agents and/or other diagnostic drugs. Experience with metabolic imaging, nuclear medicine or MRI contrast agents is considered an advantage.

• Broad experience with technologies in several medical fields (e.g. oncology, neurology, cardiology) is considered an advantage.

• Excellent leadership, communication, and interpersonal skills. Strong track record on successful interactions with Key Opinion Leaders and Top Tier Academic Researchers.

• Strong problem-solving mindset with a proven ability to navigate complex decisions and align clinical strategies with scientific and business objectives.

• Attractive compensation package, including a competitive base salary and stock options

• Key role in a highly advanced and fast-growing startup company

• Impactful product promoting better understanding and treatment of cancer

• International team, from over 20 different nationalities

• Positive work environment with open communication and a collaborative mindset

• A hybrid working model at state-of-the-art facilities based in Ulm, Germany.

• Indefinite employment contract

• 30 vacation days

• Flexible working hours

• Annual health budget (Allianz bKV)

• EGYM Wellpass

• Relocation support

Join us in making a difference! Submit your application to be considered for this exciting opportunity.

Emilija Stojanovska
Sr. Talent Acquisition Manager
mail: careers@nvision-imaging.com

NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are just leaving stealth mode, moving from local R&D to global commercialization and expansion.

We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body, with tremendous potential for research and applications in oncology, cardiology, neurology and more. Our company brings together expertise in physics, chemistry, engineering and medicine, and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York, MD Anderson in Texas, Technical University of Munich, Cambridge University in the UK and more.

NVision is developing fast, robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast, fully-automated, multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in-house.

We offer a dynamic international working environment, with immense room for growth, that encourages personal initiative and open communication.