דרושים » מדעי החיים, טבע וחקלאות » Senior Software Engineer Research Department

A fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global and every individual at is part of a life-saving mission.
About our technology
developed a digital imaging platform using novel computational photography. Built on top of this breakthrough technology is clinical-grade AI that automatically analyzes blood samples at the highest resolution available and in minutes. has secured FDA clearance for its Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application and its technology is in commercial use at hospitals and labs in the US, Europe, and Israel.
About the position
We are seeking an experienced and dynamic Clinical Affairs Team Lead to join our growing company. This role is pivotal in ensuring successful execution of our clinical trial portfolio and alignment with regulatory and business objectives. The ideal candidate will have proven managerial and operational expertise in clinical trial execution and team leadership, coupled with a strong scientific background. This is an opportunity to lead a dedicated team and contribute directly to the success of the business.

What youll be doing
Clinical Trial Management: Lead and oversee the execution of multiple ongoing clinical trials, secure the successful completion of studies, and meet timelines and quality standards
Operational Excellence: Develop and optimize clinical trial processes, ensuring efficient workflows and compliance with regulatory standards
Stakeholder Collaboration: Act as the primary liaison between internal teams, external partners, and clinical sites to ensure alignment and effective communication
Regulatory Compliance: Ensure all clinical activities adhere to regulatory requirements, including those of FDA, CE, and other relevant authorities
Data Integrity: Oversee data collection, management, and reporting to ensure accuracy and reliability in support of regulatory submissions and business goals
Risk Management: Identify potential challenges and proactively implement solutions to mitigate risks to clinical trial success
Strategic Planning: Contribute to the development and execution of the clinical strategy in alignment with the companys goals and assume responsibility for clinical study design

a rapidly growing medical technology company revolutionizing hematology and cell morphology analysis. Our mission is to facilitate quicker, earlier detection and diagnosis of blood-related diseases, ultimately leading to improved patient outcomes. At every team member plays a crucial role in our life-saving mission.

About our technology
developed a groundbreaking digital imaging platform utilizing innovative computational photography and clinical-grade AI. This platform automatically analyzes blood samples at the highest resolution available and delivers results within minutes. Our Full-Field Peripheral Blood Smear Application has received FDA clearance, and our technology is currently in commercial use across hospitals and labs in the US, Europe, and Israel.

What youll be doing
Collaborating with cross-functional R&D teams to enhance development and testing processes
Designing and developing test infrastructure, both back-end and front-end
Creating and executing comprehensive test plans, test suites, and test scripts to validate functionality, performance, integration, and security
Reporting metrics, test results, and defects to stakeholders
Developing, executing, and maintaining automated testing frameworks
Preparing and maintaining relevant documentation and technical guidelines

We are looking for an experienced Clinical MD to manage and oversee our clinical development plan and the medical aspects of advanced-stage clinical trials. In this role, the Clinical MD will address medical inquiries throughout the trial process, contribute to protocol development, and participate in ongoing trial monitoring, including preparing Clinical Study Reports (CSR).

Additionally, the Clinical MD will work closely with internal and external stakeholders to shape the clinical strategy, helping to define the optimal trial path and medical indications required for FDA approval.

Key Responsibilities
Provide medical consultation and support throughout advanced clinical trials, demonstrating a deep understanding of the clinical research process.
Contribute to developing clinical trial protocols, ensuring scientific accuracy and full regulatory compliance.
Oversee the execution of clinical studies, including process monitoring and preparation of Clinical Study Reports (CSRs) summarizing key findings.
Participate in defining the optimal types of trials and clinical indications to support a strong case for FDA approval.
Manage and support the execution of complex clinical programs, including multiple concurrent trials designed to generate comprehensive and robust data.
Supervise small-scale pharmacological studies focusing on pharmacokinetic (PK) and pharmacodynamic (PD) parameters.
Lead preparations for regulatory meetings (e.g., IND), including analysis and interpretation of preclinical pharmacology and PK/PD data.
Define clinical trial objectives and endpoints as part of the overall strategy, ensuring alignment with both medical standards and regulatory expectations.

We are looking for a nonclinical lead with a toxicology and nonclinical drug development background to join our team. The role involves managing all nonclinical studies, scientific review of study plans, regulatory document review and writing, and participation in strategic discussions.

Key Responsibilities
Management and monitoring of all non-clinical studies
Review and oversee nonclinical studies Provide expert evaluation and guidance on nonclinical study plans and reports.
Regulatory support Review regulatory documents as a nonclinical SME and contribute to regulatory writing (IB, submission documents) as needed.
Strategic input in nonclinical development Offer expert guidance on nonclinical development strategies.
Participation in team meetings provide updates on study monitoring
Expert consultation Take part in dedicated expert meetings as needed.