Description
About our company
We are looking for a Scientific Lead who will work on the scientific part of a clinical regulatory process for our medical device and will also work to extend the company's product pipeline, i.e., potentially adding other types of cancer to our pipeline.
Women lack reliable breast cancer (BC) screening methods, as 50% of BCs are detected in a late stage. At The Blue Box, we've developed a radiation-free, pain-free, low-cost device detecting breast cancer from volatile organic biomarkers in urine with a sensitivity of 88%. This outperforms mammography by 15% across all age groups and by 30% for women under 50.
Job Description
The responsibilities of the Scientific Lead will be:
- Design and conduct protocols and experiments for device validation and record data according to established protocols together with our laboratory technician.
- Analyze experimental data and interpret the results. Extract conclusions to define product specifications.
- Be the ultimate responsible for laboratory facilities, ensuring that these are compliant with the industry’s quality standards.
- Collaborate with an external partner (CRO) for the execution of clinical trials for product validation. Manage activity requirements and timings to ensure successful project completion.
- Preparation of documents for the technical file in collaboration with our QA/RA (Quality Assurance/Regulatory Affairs) department.
- Lead efforts to present research findings at conferences and industry events to enhance the company's visibility. Collaborate with internal and external stakeholders to ensure the timely submission of manuscripts to reputable scientific journals.
- Develop and maintain relationships with key opinion leaders and researchers in the medical community.
- Manage the planning, execution, and publication of scientific studies that demonstrate the efficacy and reliability of the company's diagnostic products.
- Collaborate in the preparation and design of R+D public funding applications.
- Collaborate with other team members to achieve project goals and deadlines, and be responsible for mentoring team members in the R+D department.
- Be in charge of the company’s scientific research activities to expand our current product to other diseases or other types of cancer
- Collaborate with the CTO to translate scientific knowledge into improvements for our product.
Requirements
- Master's degree in a scientific or health-related discipline (e.g., Pharmacy, Biology, Biochemistry, or related field). A PhD degree or three years of experience in life sciences-related research.
- Extensive experience working in a laboratory, designing and performing experiments.
- Experience manipulating human samples, ideally acquiring metabolite profiles (e.g. GC-MS) and interpreting and extracting biological conclusions from laboratory experiments.
- Experience writing experimental protocols and reports under quality standards, technical documentation, and record control sheets (working under SOPs and WIs).
- Being capable of working independently and within a team.
- Fluency in English.
- Knowledge of additional European languages is a plus.
- Previous experience in product and process validation in the medical device or pharma industries is a plus. For example, participation in the design/execution of a clinical trial.
- Knowledge of complex statistical methods for data analysis is a plus.
- Experience designing and executing clinical trials to test the performance of a diagnostics device or drug is a plus
- Experience with Regulatory Affairs activities in the US and communications with the CE FDA is a plus.
About the team
This is an in-person job with one optional work-from-home day per week. Our office space is at StartUB! (Barcelona) and we’ll be conducting lab work in Poblenou area. The current team is integrated by 7 people: CEO, CTO, COO, QA/RA Manager, Project Manager, Lab Technician, and R+D Engineer. Meet part of the team here.
*Wanna know more? TechCrunch featured us in this article: techcrunch.com/the-blue-box.
*Here are our social media platforms: linkedin, twitter, instagram.
How to apply
To apply, please submit your application to [email protected], including:
- Your CV
- When you’d be able to start working with us. If you need to relocate to Barcelona, when you’d be able to start working in person
- If you fulfill our mandatory and non-mandatory requirements