Research Assistant – AI-Based Analysis Tool for Prostate Cancer

Do you want to contribute to top quality medical research?

The Department of Medical Epidemiology and Biostatistics conducts research in epidemiology and biostatistics across a broad range of biomedical areas. The department is among the largest of its kind in Europe and has particularly strong research profiles in psychiatric, cancer, reproductive, pediatric, pharmacological, genetic, and geriatric epidemiology, eating disorders, precision medicine, and biostatistics. The department is located on the Solna campus. More information can be found at ki.se.

Your mission

We are now seeking a research assistant with experience in regulatory processes for medical devices, with a particular focus on software as a medical device (SaMD).

The position involves supporting the regulatory and project work for ClinAI Prostate – an AI-based analysis tool for digital pathology in prostate cancer. The work will be carried out in close collaboration with clinical partners across Europe and other international collaborators in diagnostics and regulatory affairs.

This is a fixed-term, part-time position (50% of full-time) for six months.

Duties

• Support the coordination of the development of AI tools in digital pathology and multimodal data.
• Assist in regulatory work related to prospective evaluation of AI tools within clinical trials.
• Contribute to the development of regulatory strategies for both the EU and the US, in order to enable prospective testing within the context of clinical trials. This may include helping to ensure that the project complies with relevant regulations and standards.
• Assist with coordinating activities between the research group, external regulatory consultants, and industrial partners.
• Contribute to the preparation of technical documentation, risk management, validation and verification plans required for the prospective evaluation of AI tools in clinical trials.
• Contribute to the development and improvement of the Quality Management System (QMS) and Information Security Management System (ISMS).
• Assist in preparing interactions with regulatory authorities, such as the Swedish Medical Products Agency (Läkemedelsverket).
• Compile documentation and report progress to the project lead and research group leaders.
  
  

Your profile

Qualifications

• A university degree at Master’s level (or equivalent) in a relevant field, such as life sciences, medical technology, engineering or business administration. An MBA, completed or in progress, is an advantage.
• Knowledge of regulatory processes for medical devices and clinical diagnostics, preferably software as a medical device (SaMD) and AI-based tools.
• Familiarity with the CE-IVDR and/or FDA regulatory frameworks.
• Basic understanding of clinical trials, preferably within oncology.
• Good organisational and project coordination skills, with the ability to keep track of multiple tasks and stakeholders.
• Excellent command of English, spoken and written.
• Ability to work in an international environment.
• Driven and adaptable, with good analytical and problem-solving skills and the capacity to learn quickly.

Merits

• Professional experience, preferably international, from clinical or product development of AI-enabled software as a medical device (SaMD).
• Practical experience of working on projects under CE-IVDR and/or FDA frameworks.
• Experience from prostate cancer research or clinical oncology studies.
• Experience of projects in digital image analysis or AI development, particularly with applications in prostate cancer (e.g. PSMA imaging).
• Experience of data quality and annotation governance for AI development.
• Experience of implementing clinical diagnostics in healthcare or in sponsor-led clinical trials.
• Experience of collaborating across academia, healthcare and industry, and of working in or with several countries, particularly in Europe and the United States.

Personal Qualities

We are looking for a structured and results-oriented person with strong drive and an interest in translating regulatory requirements into practical solutions. You can work independently as well as in a team, you thrive in a dynamic research environment and you enjoy collaborating across organisational boundaries. We attach great importance to personal qualities in this recruitment.

What do we offer?

A creative and inspiring environment with wide-ranging expertise and interests. Karolinska Institutet is one of the world's leading medical universities. Our vision is to pursue the development of knowledge about life and to promote a better health for all. At Karolinska Institutet, we conduct successful medical research and hold the largest range of medical education in Sweden. Karolinska Institutet is also a state university, which entitles you to several good benefits through our collective agreement. And you get to practice freely in our modern wellness facilities, where trained staff are on site.

Location: Solna

Choose to work at KI – Ten reasons why

Application

KI applies individual and differentiated salary setting in accordance with our collective agreements RALS and RALS-T.

The application is to be submitted through the Varbi recruitment system.In this recruitment, you will apply with your CV without a personal letter. Instead, you will answer some questions about why you are applying for the job in the application form.

Want to make a difference? Join us and contribute to better health for all