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
Bachelors degree in life sciences, health sciences, or related field; Masters, Ph.D., or equivalent preferred
A minimum of five years of operational experience, with at least two years in a team leadership role
Proven track record of successfully managing clinical trials from initiation to completion
Strong operational skills with experience in process optimization
Excellent team management skills, with a collaborative and problem-solving mindset
Exceptional organizational, communication, and interpersonal skills
Ability to manage multiple priorities in a fast-paced environment
Experience in the medical device or diagnostics industry is highly desirable
English proficiency
