Head of Clinical Development (m/f/d)

NVision Imaging Technologies; Deutschland; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An innovative firm is seeking a Head of Clinical Development to lead clinical trial strategies for advanced MRI technology. This pivotal role involves collaborating with academic centers, managing clinical trials from design to execution, and ensuring adherence to regulatory standards. The ideal candidate will have a strong background in clinical trial design and a proven track record in bringing medical technologies to market. Join a dynamic team in a fast-growing startup that values collaboration and offers a remote or hybrid working model, competitive salary, and attractive benefits.

Leistungen

Attractive compensation package

Stock options

30 vacation days

Flexible working hours

Annual health budget

Relocation support

Positive work environment

Remote or hybrid working model

Qualifikationen

• Advanced degree in a scientific or medical field is required.
• Proven track record in clinical trial management and regulatory approval.

Aufgaben

• Lead clinical trial strategies and ensure compliance with regulations.
• Manage clinical trial budgets and timelines effectively.

Kenntnisse

Clinical Trial Design

Leadership Skills

Regulatory Knowledge

Problem-Solving

Communication Skills

Ausbildung

MD or PhD in relevant field

Tools

Clinical Research Organizations (CROs)

Jobbeschreibung

Your mission

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.

Your profile

• 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.

Why us?

• 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 remote or hybrid working model at state-of-the-art facilities

• Indefinite employment contract

• 30 vacation days

• Flexible working hours

• Annual health budget (Allianz bKV)

• EGYM Wellpass

• Relocation support

contact information

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

Any questions? Please contact:

Emilija Stojanovska
Sr. Talent Acquisition Manager
mail: [e-mail]