Translational Scientist - Hybrid

Role Summary

Translational Scientist plays a key role in bridging scientific insight and regulatory requirements for development of Next-generation sequencing (NGS) based in vitro diagnostics (IVDs), with a focus on technical documentation throughout the product life cycle and cross-functional collaboration. This role will support analytical verification and validation activities including but not limited to study designs, sample requirements, protocol and report writing and will ensure those executing study protocols understand the scientific rationale. The Translational Scientist will also serve as a liaison between Product Development and Quality Assurance/Regulatory Affairs to ensure the product development process aligns with applicable regulatory requirements. This position requires strong interpersonal and organizational skills in addition to scientific writing skills and regulatory awareness for supporting regulatory submissions of NGS based companion diagnostics (CDx) devices at Caris.

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.

Qualifications

• 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.
• Required: Strong scientific writing experience (e.g., validation documents, protocols, SOPs, peer-reviewed publications).
• Required: Solid understanding of molecular biology principles and assay development processes.
• Required: Familiarity with Design Control and product development within a regulated (IVD or medical device) environment.
• Required: Ability to work effectively across interdisciplinary teams and manage multiple priorities.
• Required: Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working.
• Required: Knowledge of Internet for business use.
• Preferred: Hands-on or scientific knowledge of Next-Generation Sequencing (NGS) platforms and applications.
• Preferred: Experience working within Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR.
• Preferred: Experience with IVD or SaMD product development and regulatory submissions (510(k), PMA, IVDR, etc.).
• Preferred: Familiarity with analytical validation principles including standards (e.g., CLSI guidelines).

Physical Demands

• Primarily office-based role with standard office equipment use.
• Prolonged periods of sitting and working at a computer.
• Must be able to lift standard office supplies or light equipment if needed.