Sr Director, Translational Research Scientist - MD/PhD

Core Accountabilities

• Design and Execute Translational Study Plans
• Develop and validate experimental models, assays, and protocols
• Analyze and interpret study data
• Manage data integrity and study documentation
• Identify subject matter expert collaborators
• Maintain awareness of study progress
• Establish and maintain open lines of communication
• Facilitate exploratory research
• Act as the internal expert on clinical application, technical performance, and limitations of treatment platforms
• Translate clinical experience into insights related to safety, efficacy, usability, and procedural outcomes
• Identify and characterize patient subgroups most likely to benefit
• Convert clinical findings into actionable inputs for product development and design evolution
• Influence product roadmap and development priorities based on real-world clinical use
• Support validation of safety and efficacy for products not yet on label across multiple trials
• Collaborate on which investigators and KOLs to prioritize
• Ensure coordinated outreach and consistent communication
• Support harmony between clinical trial activity and existing commercial product presence while maintaining strict compliance boundaries for not-on-label products
• Partner Collaboration: Collaborate closely with strategic alliance partners conducting sponsored studies
• Study Guidance: Provide clinical and technical oversight to ensure sponsored studies align with overall product strategy, evidence-generation goals, and data quality expectations
• Outcomes Integration: Maintain visibility into progress, learnings, and outcomes from strategic alliance-led studies

Qualifications

• Education: MD/PhD, or equivalent advanced degree in bioengineering, biomedical engineering, physiology, pharmacology, or related field
• Experience: 5+ years experience in translational research for medical devices, combination products, or biologics with direct responsibility for study design and execution
• Skills: Strong organizational skills, attention to detail, and ability to manage multiple projects and timelines; Excellent written and verbal communication skills essential for successful long-term relationships with external collaborators; Ability to analyze complex biological and engineering data, produce study reports, and present findings to technical and nontechnical stakeholders
• Prior experience: Prior experience building or managing a research laboratory including lab technicians, PhD students/candidates, and/or postdoctoral researchers; Understanding of regulatory pathways for medical devices (e.g., FDA and EU requirements) and experience designing studies to support submissions; Experience with GLP-compliant study execution or working with CROs under GLP frameworks; Experience establishing external academic or CRO partnerships and negotiating study agreements