Caris Life Sciences · 3 days ago
Translational Scientist - Hybrid
Tempe, AZ
Full-time
Hybrid
Senior Level
5+ years expCaris Life Sciences is dedicated to transforming cancer care and improving lives through precision medicine. The Translational Scientist plays a key role in bridging scientific insight and regulatory requirements for the development of NGS-based IVDs, focusing on technical documentation and cross-functional collaboration.
Artificial Intelligence (AI)BiopharmaBiotechnologyHealth CareLife Science
Responsibilities
Composes scientific and technical documents throughout the product development process through collaboration with cross-functional teams including Product Development, Bioinformatics/Statisticians, Molecular Operations, QA, and RA
Support analytical verification and validation (V&V) studies for oncology-focused IVD assays:
Contribute to study design and sample planning
Draft and review V&V protocols and reports
Ensure scientific rigor in data interpretation for analytical performance metrics (e.g., LoD, specificity, precision)
Translate complex scientific rationale into clear guidance for execution teams
Participate in cross-functional risk assessments (e.g., FMEA), design reviews and contribute to design control deliverables including design inputs, outputs and traceability
Collaborate with Regulatory Affairs to prepare and review regulatory submissions (e.g., FDA 510(k), PMA, EUA, IVDR), including pre- and post-market documents
Extract, synthesize, and format study results for inclusion in regulatory submission documents
Ensure compliance with applicable regulations including FDA 21 CFR Part 820, ISO 13485, IVDR, and country-specific requirements
Stay up to date with evolving oncology biomarkers, therapeutic targets, and regulatory guidance relevant to oncology diagnostics and companion diagnostics (CDx)
Must be tolerant to change, ready to take on new challenges and open to learning new skills
Qualification
Required
MS degree in Molecular Biology, Biochemistry, Pharmacology, or a related life sciences field with 5+ years of relevant industry experience; or a PhD with relevant training and experience
Strong scientific writing experience (e.g., validation documents, protocols, SOPs, peer-reviewed publications)
Solid understanding of molecular biology principles and assay development processes
Familiarity with Design Control and product development within a regulated (IVD or medical device) environment
Ability to work effectively across interdisciplinary teams and manage multiple priorities
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working
Knowledge of Internet for business use
Preferred
Hands-on or scientific knowledge of Next-Generation Sequencing (NGS) platforms and applications
Experience working within Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR
Experience with IVD or SaMD product development and regulatory submissions (510(k), PMA, IVDR, etc.)
Familiarity with analytical validation principles including standards (e.g., CLSI guidelines)
Company
Caris Life Sciences
Caris Life Sciences develops molecular profiling and AI-driven technologies to support precision medicine in oncology.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.86BKey Investors
BraidwellOrbiMedSixth Street
2025-06-18IPO
2025-04-07Private Equity· $168M
2023-01-19Debt Financing· $400M
Leadership Team
Luke Power
Chief Financial Officer
Brian Stengle
SVP, Chief Marketing Officer
Recent News
Investor's Business Daily
2026-01-13
2026-01-12
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