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.

- These may include in vitro, ex vivo, and/or in vivo studies to evaluate mechanism of action, performance, and safety of medical devices

- Develop and validate experimental models, assays, and protocols that characterize clinical outcomes and support regulatory filings

- Analyze and interpret study data then synthesize findings into study reports focusing on implications for medical device development and clinical study design.

- Manage data integrity and study documentation per requirements including GLP (Good Laboratory Practice)/GCP (Good Clinical Practice) best practices for research.

- Relationship Building: Identify subject matter expert collaborators. Build and sustain strongdeep, trusted relationships with collaborating investigators, labs and study sites.

- Site Awareness: Maintain awareness of study progress with collaborating labs.

- Communication: Establish and maintain open lines of communication with principal investigators and collaborating scientists.

- Subject Matter Representation: Serve as a trusted collaborator to investigators and site teams, capable of discussing the underlying science and potential implications for medical device design as well as clinical implications..

- Exploratory Research: Facilitate exploratory research by identifying opportunities for sub-studies, brainstorming novel investigation areas, and assisting with publication efforts.

- Act as the internal expert on the 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 , including anatomical, physiological, and disease-specific factors.

- 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.

- Serve as a key communication bridge with Commercial teams to ensure alignment across shared clinical and commercial pulmonary sites .

- Provide regular, structured updates on site activity, investigator engagement, and trial progress.

- Collaborate on which investigators and KOLs to prioritize , ensuring 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, i.

- Integrating thesee insights from sponsored external studies into internal clinical, engineering, and product decision-making.

- Strategic Connector: Serve as the primary liaison aligning Engineering, Clinical Affairs, Medical Affairs, Regulatory, and Data Analytics with data generated from translational projects.

- Commercial Readiness: Ensure that learnings and data from studies are packaged to support regulatory submissions, device design, clinical study design, and marketing claims.

- Function Building: Define the standard operating procedures for the translational research scientist feedback loop within the organization.

- Mentorship & Growth: Recruit, train, and mentor a growing team of translational research scientists and specialists as the product pipeline matures.

- Build and manage external collaborations with academic labs, contract research organizations (CROs), and clinical partners to expand capacity and access specialized expertise.

- Scale translational capabilities: develop standardized models, assay platforms, and automation to increase throughput and reproducibility (ie biospecimen processing - staining and imaging, data storage, data sharing, data interpretation, others)

- Coordinate across Clinical, Engineering, Medical, Regulatory, Data Analytics, Commercial, and Strategic Alliance teams.

- Ensure clinical and technical insights are captured, analyzed, and disseminated in a timely and structured manner.

- As clinical activity scales, help define team structure and lead the growth of a clinical engineering learnings function.

- Establishment and maintenance of strong, trusted external collaborators

- Timely design and execution of studies based on predefined expectations.

- Actionable insights influencing device design and clinical study design.

- Demonstrated impact on product validation, design, and roadmap decisions.

- Effective alignment between internal teams and external collaborators.

- High-quality study documentation, peer-reviewed publications, and conference presentations that strengthen scientific credibility.

- Growth and retention of a high-performing translational research team.

- 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.

- 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: 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.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

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.

• 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: 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. Primary Function of Psoition:

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.

• These may include in vitro, ex vivo, and/or in vivo studies to evaluate mechanism of action, performance, and safety of medical devices

• Develop and validate experimental models, assays, and protocols that characterize clinical outcomes and support regulatory filings

• Analyze and interpret study data then synthesize findings into study reports focusing on implications for medical device development and clinical study design.

• Manage data integrity and study documentation per requirements including GLP (Good Laboratory Practice)/GCP (Good Clinical Practice) best practices for research.

• Relationship Building: Identify subject matter expert collaborators. Build and sustain strongdeep, trusted relationships with collaborating investigators, labs and study sites.

• Site Awareness: Maintain awareness of study progress with collaborating labs.

• Communication: Establish and maintain open lines of communication with principal investigators and collaborating scientists.

• Subject Matter Representation: Serve as a trusted collaborator to investigators and site teams, capable of discussing the underlying science and potential implications for medical device design as well as clinical implications..

• Exploratory Research: Facilitate exploratory research by identifying opportunities for sub‑studies, brainstorming novel investigation areas, and assisting with publication efforts.

• Act as the internal expert on the 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 , including anatomical, physiological, and disease-specific factors.

• 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.

• Serve as a key communication bridge with Commercial teams to ensure alignment across shared clinical and commercial pulmonary sites .

• Provide regular, structured updates on site activity, investigator engagement, and trial progress.

• Collaborate on which investigators and KOLs to prioritize , ensuring 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, i.

• Integrating thesee insights from sponsored external studies into internal clinical, engineering, and product decision-making.

• Strategic Connector: Serve as the primary liaison aligning Engineering, Clinical Affairs, Medical Affairs, Regulatory, and Data Analytics with data generated from translational projects.

• Commercial Readiness: Ensure that learnings and data from studies are packaged to support regulatory submissions, device design, clinical study design, and marketing claims.

• Function Building: Define the standard operating procedures for the translational research scientist feedback loop within the organization.

• Mentorship & Growth: Recruit, train, and mentor a growing team of translational research scientists and specialists as the product pipeline matures.

• Build and manage external collaborations with academic labs, contract research organizations (CROs), and clinical partners to expand capacity and access specialized expertise.

• Scale translational capabilities: develop standardized models, assay platforms, and automation to increase throughput and reproducibility (ie biospecimen processing – staining and imaging, data storage, data sharing, data interpretation, others)

• Coordinate across Clinical, Engineering, Medical, Regulatory, Data Analytics, Commercial, and Strategic Alliance teams.

• Ensure clinical and technical insights are captured, analyzed, and disseminated in a timely and structured manner.

• As clinical activity scales, help define team structure and lead the growth of a clinical engineering learnings function.

• Establishment and maintenance of strong, trusted external collaborators

• Timely design and execution of studies based on predefined expectations.

• Actionable insights influencing device design and clinical study design.

• Demonstrated impact on product validation, design, and roadmap decisions.

• Effective alignment between internal teams and external collaborators.

• High-quality study documentation, peer-reviewed publications, and conference presentations that strengthen scientific credibility.

• Growth and retention of a high-performing translational research team.