Job description
Job description
🚨 IMPORTANT: Application guideline
In order for your application to be read, email careers@stratifai.com with your CV, and title of the email "PM - LI". Applications through LinkedIn will not be considered.
🚀 We’re Hiring: Product Manager - Laboratory Integration (US) (w/m/d)
📍 Location: Berlin, On-Site (Hybrid)
WHO WE ARE
StratifAI is an innovative Berlin-based precision oncology startup developing the next generation of AI-based cancer biomarkers. The founders have published over 100 articles in top-tier journals and founded StratifAI to translate these novel ideas into patient care.
Our products enable cancer patients to receive the right treatment at the right time - both for existing drugs on the market, and by supporting pharmaceutical companies in developing the drugs of tomorrow.
OUR CORE VALUES
1️⃣ Trust, honesty & open communication between everyone
2️⃣ Saving time >>> money. Moving fast, 80/20 principle
3️⃣ Mistakes are ok as long as we learn from them, fast
4️⃣ We aim to be the best and deliver the highest quality, without egos
WHAT WE OFFER
🌟 The opportunity to make a real difference for cancer patients.
💼 Competitive salary, stock options and extra benefits.
🏢 A beautiful office near Alexanderplatz with an on-site gym, private showers, free drinks and snacks, rooftop bar, co-working space, and a quiet room for meditation or prayer.
🏆 Competing at the global top-tier of cancer research together with the founders, who are renowned researchers in the field of AI for biomarker development from medical imaging.
⚡ An extremely fast-paced and high-growth VC-funded start-up environment with key ownership from day 1.
JOB DESCRIPTION
As the product manager you will be responsible for leading the integration of our AI-based biomarkers as Lab Developed Tests (LDTs) into laboratory environments. You will play a key role in identifying crucial software components and features, defining how our software integrates into clinical workflows. Your responsibilities will also include supporting regulatory compliance and facilitating secure data transfer processes. This role is externally facing and deeply explorative, ideal for someone who thrives at the intersection of innovation, healthcare, and operations.
KEY RESPONSIBILITIES
- Drive the integration of our AI-based biomarkers into laboratories as digital lab-developed tests (LDTs)
- Translate clinical, laboratory, and regulatory requirements into actionable product specifications for technical teams and refine the product backlog.
- Ensure all processes, documents and product developments align with relevant quality and regulatory standards (e.g., ISO 13485, ISO 27001, GDPR/HIPAA)
- Contribute to the creation and maintenance of technical documentation
- Design validation studies to support the integration of our tests into laboratory environments.
- Lead cross-functional sprint planning, reviews, and product releases.
- Define, monitor, and iterate on key product performance metrics and user feedback.
- Participate in user research to continuously validate hypotheses and inform roadmap decisions.
REQUIRED EXPERTISE
- 5+ years of experience in product management, preferably in digital health, medical software, or AI/ML applications in healthcare.
- Hands-on experience with CMS package application for LDTs
- Demonstrated understanding of laboratory and hospital operations, with experience supporting clinical diagnostics or wet lab workflows.
- Familiar with the full sample journey within a laboratory environment
- Strong grasp of software development processes, agile methodologies, and backlog management tools (e.g., Jira).
- Familiar with regulated software development under ISO 13485 and ISO 27001.
- Knowledge of healthcare data standards (e.g., HL7, FHIR) and clinical validation studies.
- Excellent communication skills; able to clearly convey technical topics to clinical stakeholders and translate clinical needs for technical teams.
- Experience collaborating cross-functionally in startup or other fast-paced environments.
- Fluent in English
GOOD TO HAVE
- Experience integrating digital products into laboratory information systems (LIS), hospital information systems (HIS), or electronic health records (EHR).
- Prior work in biotech, pharma, or with lab-developed tests (LDTs), particularly at the interface of software and molecular diagnostics.
- Hands-on involvement with audit preparation, technical documentation, or quality management systems.
