Project Manager – 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 http://ki.se/meb.

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

The position entails primary responsibility for leading 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.

The position is a six-month fixed-term employment at 50%.

Your mission

• Lead and coordinate the development of AI tools in digital pathology and multimodal data.
• Lead regulatory work related to prospective evaluation of AI tools within clinical trials.
• Develop regulatory strategies for both the EU and the US, in order to enable prospective testing within the context of clinical trials. This may involve to ensure that the project complies with relevant regulations and standards.
• Coordinate activities between the research group, external regulatory consultants, and industrial partners.
• Be responsible for 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).
• Handle interactions with regulatory authorities, such as the Swedish Medical Products Agency (Läkemedelsverket).
• Report progress, compile documentation, and communicate results to research group leaders and collaborators.

Your profile

Qualifications

• MBA completed or in progress at the time of application.
• Experience with regulatory processes for medical devices, clinical diagnostics, and preferably SaMD/AI-based tools.
• At least two years of international operational industrial experience in clinical or product development of AI-enabled software as a medical device (SaMD).
• Practical experience managing projects under CE-IVDR and/or FDA frameworks.
• Good understanding of clinical trials, preferably within oncology, with a particular focus on prostate cancer.
• Strong project management skills, with experience coordinating multiple stakeholders and complex workflows.
• Excellent command of English, spoken and written.
• Experience working in an international environment. Experience from working in or with several different countries, particularly in Europe and the United States, is highly valued.
• Experience with projects in digital image analysis or related fields; experience involving AI development with applications in prostate cancer (e.g. PSMA imaging) is considered particularly meritorious.
• Experienve of data quality and annotation governance for AI development
• Driven and adaptable professional with strong critical thinking, problem-solving abilities, and a proven capacity to learn quickly in dynamic environments.

Merits

• Experience in prostate cancer research or clinical oncology studies.
• Industrial experience with implementing clinical diagnostics in healthcare or in sponsor-led clinical trials.
• Experience collaborating across academia, healthcare, and industry.

Personal Qualities

We are looking for a structured and results-oriented individual with strong drive and the ability to translate regulatory requirements into practical solutions. You are used to working independently but also thrive in a dynamic research environment and enjoy leading collaborations across organizational boundaries. We attach great importance to personal qualities in the selection process.

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.

Choose to work at KI – Ten reasons why
International staff

Location: Solna

Application

Welcome to apply!

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