At Alamar Biosciences, we’re on a mission to transform the field of proteomics for the early detection of diseases. We have created the world’s most sensitive proteomics platform to unmask the deepest secrets of our proteome. Our fully automated, high throughput platform is empowering new biomarker discoveries for early detection and prevention of common diseases. We provide exceptional opportunities for those who have the entrepreneurial spirit, enjoy developing novel technologies and products, and aspire to grow together with the company.

We are seeking a Director, Clinical Assay Development to lead the development of novel clinical immunoassays using Alamar’s NULISA/ARGO platform. The ideal candidate is a proven R&D leader with extensive hands-on experience in clinical immunoassay development and a strong understanding of IVD product development process in compliance with FDA and CE-IVD/IVDR regulatory requirements. In this position, you will lead clinical diagnostic assay programs for Alzheimer’s disease and other diseases according to the Company’s product roadmap.

Primary Responsibilities:

• Lead clinical assay development from feasibility to clinical evaluation studies according to Company design control process
• Provide leadership and technical expertise in experimental design, execution and data analysis following CLSI guidelines
• Ensure robust clinical performance by conducting assay optimization, stability testing, interference testing, etc.
• Draft technical documents and reports to support regulatory submissions
• Provide expert leadership in troubleshooting and assay optimization
• Work closely with biostatistics/data science groups to align study designs and acceptance criteria
• Build and manage team by coaching and fostering teamwork
• Collaborate across company to contribute to strategic direction and ensure product meets technical and business criteria
• Collaborate with external key opinion leaders in assay development and validation

Requirements:

• Ph.D. or equivalent in molecular biology, biochemistry, immunology or a related field
• 14+ years working in life science/diagnostic industry with a track record of clinical-grade immunoassay development
• In-depth knowledge of industry standards including CLSI guidelines related to immunoassays
• Multiplex clinical immunoassay development experience is highly desirable.
• Hands-on experience with qPCR and/or NGS molecular assay development a plus
• Experience in IVD product development and regulatory submissions
• Proven leadership in building and growing technical teams
• Strong communicator within and outside of the Company
• Strong organizational skills and ability to adapt to shifting priorities

The base salary range for this full-time position is $200,000 - $220,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.