Clinical Development Scientist
Summary
We are seeking an experienced Clinical Development Scientist to drive assay innovation and technology evaluation within a CAP/CLIA-certified clinical laboratory. This role bridges traditional R&D with clinical operations and is ideal for a highly independent scientist who enjoys designing assays from the ground up, troubleshooting complex workflows, and leading feasibility, optimization, and validation studies. The ideal candidate has deep hands-on experience with nucleic acid–based assays and thrives in a fast-paced environment where scientific creativity meets regulatory rigor.
Key Responsibilities:
Assay Research & Development
- Lead the end-to-end development of new molecular assays (using DNA, RNA, cfDNA, applications such as WGS, WES, methylation, single cell etc.) from concept through clinical implementation.
- Independently evaluate, design, and optimize experimental workflows, from sample prep, through library prep, sequencing, and data QC.
- Conduct feasibility studies to assess new technologies, chemistries, and methodologies.
- Perform systematic optimization (DOE, protocol adjustments, reagent comparisons, etc.) to achieve robust assay performance.
Technology Scouting & Vendor Engagement
- Meet directly with vendors to evaluate new instrumentation, kits, consumables, chemistries, and automation solutions.
- Perform independent research comparing technologies, platforms, and method options.
- Coordinate procurement and testing of new equipment and/or materials, including bringing up vendor-agnostic workflows from scratch.
Validation & Documentation
- Design validation plans in accordance with CAP/CLIA/CMS requirements (accuracy, precision, reportable range, sensitivity/specificity, analytical validity, etc.).
- Execute validation studies, manage timelines, and coordinate sample sets and logistics.
- Analyze data rigorously and write comprehensive validation reports suitable for regulatory review and medical director approval.
- Draft and maintain SOPs, work instructions, and training materials.
Cross-Functional Responsibilities
- Train Clinical Laboratory Scientists (CLSs) on new assays, workflows, and equipment.
- Collaborate with Quality, Bioinformatics, Lab Operations, and Medical Directors to ensure smooth assay transition to production.
- Support troubleshooting of existing assays and contribute to continuous improvement initiatives.
Preferred Qualifications:
- Master’s or PhD in Molecular Biology, Genetics, Bioengineering, Biochemistry, or related field.
- 5+ years of hands-on molecular R&D experience (industry preferred), including independent method development.
- Deep expertise with DNA and RNA workflows, including extraction, QC, library preparation, sequencing and/or other molecular methods.
- Experience with FFPE, degraded samples, and/or complex clinical matrices.
- Proven ability to design, optimize, and validate assays with minimal supervision.
- Strong scientific writing skills (validation reports, protocols, SOPs).
- Familiarity with CAP/CLIA regulatory requirements for LDTs (direct experience strongly preferred).
About Inocras Inc.
Inocras Inc. is an AI-driven precision genomics company pioneering whole genome sequencing (WGS) and bioinformatics for cancer diagnostics. Our flagship assays, CancerVision™ and MRDVision™, are redefining cancer care through unmatched comprehensiveness, sensitivity, and scalability. With operations in the US and Asia, we are rapidly expanding our presence across research, biopharma, healthcare providers, and patients worldwide.
Why Join Us
At Inocras, you will have the opportunity to shape the brand of a company redefining cancer diagnostics through whole genome sequencing and bioinformatics. You’ll work at the intersection of cutting-edge science, AI, and global healthcare markets—helping us accelerate the future of precision medicine.
Location
: San Diego, CA (Onsite)
Compensation:
$95,000 - $130,000 annual salary + up to annual bonus per company policy
Reports to:
Chief Clinical Operations Officer
Benefits include:
Health, Dental, Vision, and employer covered AD&D policy.
401k plan
Paid Holidays, Sick, and PTO
