Sr Director, Translational Research Scientist - MD/PhD

Intuitive; Sunnyvale (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

PVH in Sunnyvale seeks a Translational Research Scientist to lead studies that uncover mechanisms of action for medical interventions and accelerate device development across Class II/III pulmonary devices. You will generate translational data guiding patient selection, design, and regulatory submissions, working with engineering, clinical, regulatory, and manufacturing teams.

The role emphasizes cross-functional collaboration, data integrity, and leadership to scale a growing translational

Qualifications

• Develop in vitro, ex vivo, or in vivo studies to evaluate mechanism, performance, and safety of medical devices.
• Develop and validate experimental models, assays, and protocols for clinical outcomes and regulatory filings.
• Analyze data and synthesize findings into study reports for device development and clinical study design.
• Ensure data integrity and study documentation per GLP/GCP.

Responsibilities

• Design and execute translational study plans.
• Engage investigators, labs, and study sites.
• Act as internal expert on clinical applications and device performance.
• Translate clinical findings into inputs for product development and design evolution.
• Collaborate with cross-functional teams on regulatory submissions.

Skills

Translational research

GLP/GCP knowledge

Cross-functional collab

Study design & analysis

Tools

GLP protocols

Job description

Primary Function of Position:
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 translate 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 Accountabilities & Responsibilities

• Design and Execute Translational Study Plans
  • Develop in vitro, ex vivo, 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, interpret study data, and synthesize findings into study reports focusing on implications for medical device development and clinical study design.
  • Manage data integrity and study documentation per GLP/GCP best practices.
• Investigators & Site Engagement
  • Build and sustain trusted relationships with collaborating investigators, labs, and study sites.
  • Maintain awareness of study progress with collaborating labs.
  • Maintain open lines of communication with principal investigators and collaborators.
  • Serve as a trusted collaborator to discuss science and implications for device design and clinical outcomes.
  • Facilitate exploratory research, identify sub‑study opportunities, and assist with publication efforts.
• Clinical & Technical Expertise
  • 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 sub‑groups most likely to benefit, including anatomical, physiological, and disease‑specific factors.
• Product & Engineering Learnings
  • 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.
• Commercial Collaboration & Field Harmony
  • Serve as a 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 prioritizing investigators and KOLs while maintaining strict compliance boundaries for not‑on‑label products.
• Strategic Alliances & Sponsored Studies
  • Collaborate closely with strategic alliance partners conducting sponsored studies.
  • Provide clinical and technical oversight to ensure sponsored studies align with overall product strategy, evidence‑generation goals, and data quality expectations.
  • Maintain visibility into progress, learnings, and outcomes from alliance‑led studies and integrate insights into internal decision‑making.
• Cross‑Functional Integration & Strategy
  • Serve as the primary liaison aligning Engineering, Clinical Affairs, Medical Affairs, Regulatory, and Data Analytics with data generated from translational projects.
  • Package learnings and data from studies to support regulatory submissions, device design, clinical study design, and marketing claims.
• Team Leadership & Scaling
  • Define standard operating procedures for the translational research scientist feedback loop within the organization.
  • Recruit, train, and mentor a growing team of translational research scientists and specialists as the product pipeline matures.
  • Build and manage external collaborations.