Staff Preclinical Scientist

• Develop preclinical testing strategies supporting product development, regulatory submissions, and clinical translation
• Design in vivo studies evaluating device safety, functionality, performance, and clinical relevance
• Select animal models, study endpoints, controls, and evaluation methods based on intended use and regulatory expectations
• Ensure study objectives address product risks, design questions, and performance claims
• Act as study sponsor representative for external CRO and research site activities
• Prepare study protocols, technical justifications, study reports, technical assessments, and regulatory documentation
• Oversee study conduct for regulatory, GLP, and animal welfare compliance
• Analyze and interpret preclinical data and study reports
• Identify risks, failure modes, and design improvement opportunities
• Monitor regulatory guidance and drive continuous improvement in preclinical methodologies and study designs
• Partner with R&D, Clinical, Regulatory Affairs, Biocompatibility, Toxicology, Quality, and Marketing teams across multiple projects
• Provide consultative direction and technical guidance to support high-quality product development
• Support regulatory authority interactions with scientific rationale and study interpretations
• Manage prioritization and communicate resource needs and project updates to the PMO and Manager
• Drive proactive risk resolution with team members, peers, PMO, and management
• May lead groups and supervise direct reports or contractors
• Mentor junior scientists
• Represent the company in regulatory meetings, conferences, standards committees, or industry consortia
• Communicate business-related issues or opportunities to the next management level
• Follow and ensure compliance with applicable Health, Safety and Environmental practices, regulations, policies, and procedures

• Bachelor’s or Master’s degree or PhD in biology, chemistry, toxicology, microbiology, veterinary medicine, or a related scientific discipline
• Training in animal research methodologies, pathology, or histopathology
• 5–8 years of experience in medical device, pharmaceutical, CRO, or academic research environments
• Experience designing, executing, and interpreting in vivo studies
• Experience working with external research organizations (CROs) and study sites
• Experience analyzing and interpreting preclinical data and study reports
• Working knowledge of regulatory requirements and guidance for non‑clinical studies
• Experience authoring scientific protocols, study reports, technical assessments, and regulatory documentation
• Preferred: experience in orthopedic, spine, trauma, sports medicine, or other medical device therapeutic areas

Demonstrates expertise in developing preclinical testing strategies, designing in vivo studies, and ensuring compliance with regulatory requirements. Proficient in analyzing preclinical data and providing consultative direction to support product development across multidisciplinary teams.

• In Vivo Study Design
• Regulatory Compliance
• Preclinical Data Analysis
• Scientific Protocol Authoring
• Animal Research Methodologies

• Preclinical Testing Strategies
• Study Protocol Preparation
• Technical Assessment
• Data Interpretation
• Risk Identification
• Study Endpoint Selection
• Animal Model Selection
• Regulatory Documentation
• GLP Compliance
• Study Conduct Oversight

• Mentoring
• Communication
• Consultative Direction
• Team Collaboration
• Project Management

• Medical Device
• Pharmaceutical
• CRO
• Toxicology
• Biocompatibility
• Clinical Translation
• Health and Safety Compliance
• Orthopedic
• Trauma
• Sports Medicine