Clinical Affairs Team Lead

Description

About Scopio Labs

Scopio Labs is a fast-growing medical technology company transforming the 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 Scopio Labs is part of a life-saving mission. 

About our technology

Scopio has developed a digital imaging platform using novel computational photography. Built on top of this breakthrough technology is Scopio’s clinical-grade AI that automatically analyzes blood samples at the highest resolution available and in minutes. Scopio Labs 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 you’ll 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 company’s goals and assume responsibility for clinical study design

Requirements

• Bachelor’s degree in life sciences, health sciences, or related field; Master’s, 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