Predicta Biosciences is a precision oncology company that integrates cutting-edge multiomics and liquid biopsies to create innovative diagnostic and therapeutic products. By eliminating the need for invasive bone-marrow biopsies with blood-based tests, Predicta enables earlier detection, frequent longitudinal monitoring,
and potential individualization of therapy selection.
We are seeking a highly motivated Associate Director, Clinical Laboratory, who will lead Predicta’s clinical testing team and will play a critical role in the translation of innovative assays from R&D into validated, high-quality diagnostic tests. This individual will oversee clinical testing workflows, ensuring compliance with regulatory and quality standards, and will work cross-functionally with R&D, Quality, and Regulatory teams to ensure successful product development and launch. The ideal candidate brings deep experience in clinical diagnostics, with a strong technical background in molecular biology and genomics including extensive hands-on expertise with NGS technologies and flow cytometry-based assays. Strong leadership, operational excellence, and the ability to scale laboratory capabilities in a regulated environment are essential for success in this role. This individual should be passionate about developing cutting-edge diagnostic assays and will work closely with an inter-disciplinary and cross-functional team focused on improving blood-based testing capabilities in areas including cancer detection, measurable residual disease, and other related applications.
Key responsibilities
- Lead day-to-day operations of the clinical diagnostics laboratory, ensuring compliance with all applicable regulatory and quality standards (e.g., CLIA/CAP)
- Establish and maintain laboratory processes, SOPs, and quality systems to ensure reproducibility, accuracy, and audit readiness
- Collaborate closely with the R&D team to translate novel assays and technologies into clinically validated, robust, and scalable diagnostic workflows
- Work closely with the R&D team to design and execute clinical validation studies to support regulatory submissions and product claims
- Partner cross-functionally with R&D, Quality, and Product teams to drive successful assay transfer, verification, and launch
- Manage, mentor, and develop laboratory staff, fostering a compliance-focused culture of scientific excellence
- Serve as a technical and operational subject matter expert for laboratory staff and during external audits, inspections, and regulatory interactions
- Ensure proper documentation, data integrity, and traceability in accordance with GxP and organizational standards
- In partnership with the R&D team, evaluate and implement new technologies, instrumentation, and workflows to support product optimization and development
Experience needed
- Advanced degree (MS or PhD) in molecular biology, biochemistry, genetics, bioengineering, or a related field, or BS with significant industry experience, with 5+ years of relevant industry experience and deep subject matter expertise
- Minimum of 5 years of hands-on laboratory experience with generating NGS libraries, sample preparation, nucleic acid extraction and quantification (PCR, qPCR), running NGS sequencers, and general molecular biology techniques
- In-depth experience with diverse NGS library preparation techniques, rigorous assay and product development practices, and characterization of analytical metrics used in benchmarking genomics assays
- Hands-on experience with flow cytometry (FACS) for assay development and optimization, including panel development, optimization, and troubleshooting
- Strong experimental design, troubleshooting, and data interpretation skills
- Proven track record of leading or supporting clinical validation studies and assay verification/transfer activities
- Extensive experience operating in a regulated environment with a solid understanding of quality systems, GxP, and data integrity principles
- Strong analytical, organizational, and problem-solving skills, with attention to detail and ability to manage multiple fast-paced projects concurrently
- Prior experience managing or mentoring laboratory and/or research staff
- Outstanding written and verbal communication skills, including experience preparing technical reports, SOPs, and regulatory documentation
Preferred qualifications
- Prior experience in a CLIA-certified and/or CAP-accredited laboratory in a leadership capacity
- Experience with advanced or emerging diagnostic technologies (e.g., NGS-based assays, liquid biopsy, multiomic assays, automation systems)
- Familiarity with laboratory information management systems (LIMS), data systems, and digital lab infrastructure
- Experience with single cell technologies (e.g. scRNA-seq, scWGS, scATAC-seq, scMultiomics using 10X Genomics and/or other single cell genomics platforms) is a plus
- Working knowledge of immunology relevant to cellular phenotyping, immune profiling, and assay interpretation
- Prior experience bringing assays from early research through to product development
Work Location
This role is based in Cambridge, MA and is a full time, on-site role.
Why Join Predicta Biosciences?
This is a unique opportunity to be part of a mission-driven team advancing precision diagnostics for hematologic cancers. You’ll play a key role in shaping the quality and performance of our clinical testing efforts and contribute directly to patient-impactful innovations.
The annual salary range for this position is $120,000 - $180,000 plus a 10% bonus opportunity. Predicta considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role. Additional rewards include equity, flexible time off, 401k Plan, medical, dental and vision plans that are 90% paid by Predicta and a partially company-funded HSA.
