Translational Scientist - LDT (Hybrid)

Caris Life Sciences•Tempe, AZ

3d•Hybrid

About The Position

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary Translational Scientist plays a key role in bridging scientific insight and regulatory requirements primarily for development of Next-generation sequencing (NGS) based Laboratory Developed Tests (LDTs) but may also include immunohistochemistry or other technologies with a focus on technical documentation throughout the product life cycle and cross-functional collaboration. This role will support validation plan and report activities including but not limited to study designs, sample requirements, plan and report writing and will ensure those executing study plans understand the rationale. The Translational Scientist will also serve as a liaison between Product Development, Office of the President, Data Science, and Quality Assurance/Regulatory Affairs to ensure the development process aligns with applicable regulatory requirements such as CAP CLIA, ISO 15189, ISO 22367. This position requires strong interpersonal and organizational skills in addition to scientific writing skills and regulatory awareness for supporting regulatory submissions of NGS based and other assays at Caris.

Requirements

MS or PhD in molecular biology, biochemistry, pharmacology, or equivalent subject matter or a minimum of 5 years relevant professional experience.
Excellent oral and written communication skills.
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 CAP/CLIA product development.
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.
Must be tolerant to change, ready to take on new challenges and open to learning new skills.

Nice To Haves

Hands-on or scientific knowledge of Next-Generation Sequencing (NGS) platforms and applications.
Experience working within Quality Management Systems (QMS) aligned with ISO 15189, CAP/CLIA, ISO 13485, FDA 21CFR820, or IVDR.
Experience with NYSDOH, IVD or SaMD product development and regulatory submissions (510(k), PMA, IVDR, etc.).
Familiarity with analytical validation principles including standards (e.g., CLSI guidelines).

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 validation studies for LDT assays: Contribute to study design and sample planning.
Draft and review validation plans 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.
Extract, synthesize, and format study results for inclusion in validation reports documents.
Ensure compliance with applicable regulations including CAP/CLIA, ISO15189, ISO 22367 and state-specific requirements.
Stay up to date with evolving biomarkers, therapeutic targets, and regulatory guidance relevant to oncology diagnostics and LDTs.
Periodically support validation studies for IVD as needed.