Sr Director, Translational Research Scientist - MD/PhD We are seeking a highly driven and experienced Translational Research Scientist to lead efforts to understand the fundamental mechanism(s) of action associated with medical interventions on patients and disease states. The ideal candidate will generate translational data which will provide a deeper understanding of the biologic effects of medical interventions to accelerate medical device development including patient selection and device design. Focusing on a portfolio of Class II and III medical devices in the pulmonary space—including next-generation pre-label products—this leader will focus on translating biological and engineering insights into device design, regulatory submissions, and clinical studies. The role will closely collaborate with engineering, clinical, regulatory, and manufacturing teams to de-risk devices and accelerate product development. Core AccountabilitiesResponsibilities Design and Execute Translational Study Plans Investigator & Site Engagement Clinical & Technical Expertise Product & Engineering Learnings Commercial Collaboration & Field Harmony Strategic Alliances & Sponsored Studies Cross-Functional Integration & Strategy Team Leadership & Scaling Cross-Functional Coordination & Team Growth Success Indicators

Required Qualifications

Education: MD/PhD, or equivalent advanced degree in bioengineering, biomedical engineering, physiology, pharmacology, or related field. 5+ years experience in translational research for medical devices, combination products, or biologics with direct responsibility for study design and execution. 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.

Preferred Qualifications

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. Location and Travel: Location: Remote / Work-from-home, with the ability to maintain working hours that partially overlap with Pacific Time. Relocation is preferred but not required for this role. Travel: Up to 20% travel required to clinical sites, partner locations, and the home office as needed.