Senior Director, Clinical Research

Company Description

Cutera, Inc. is a leading aesthetics device company with a comprehensive product portfolio and a worldwide distribution footprint. The Company’s technology enables physicians to provide sophisticated solutions for a wide range of medical aesthetic applications. We are looking for a key member to join our fast-paced R&D engineering team in changing the landscape of medical aesthetics.

Please visit www.cutera.com for more information about us!

Job Description

Position Summary:

We are seeking a Senior Director, Clinical Research to lead our clinical team in its mission to improve lives through medical aesthetic technologies driven by science​. Our products use a broad range of innovative laser and radio frequency technologies designed by our scientists and engineers to enable first-to-market applications and best-in-class products for dermatology.

As the leader of our clinical team, you will work closely with our engineering and regulatory groups to direct clinical validation and support regulatory approval for new products and expand clinical applications for existing products. Clinical trials are conducted in our on-site Cutera Research Clinic (CRC) and through collaborations with KOLs and range from feasibility to pivotal studies. You will also drive our data dissemination program through peer-reviewed publications, white papers, and podium presentations at major conferences.

The ideal candidate would have experience managing and mentoring clinical research teams, extensive operational experience in all aspects of medical device clinical studies, and a strong track record of advancing clinical research. This position provides a unique opportunity to drive innovation through the development of new medical device technologies and applications in a fast-paced R&D environment.

Duties & Responsibilities:

• Define and drive the clinical study roadmap in alignment with Cutera’s strategic objectives and partner effectively with Engineering, Marketing, and Regulatory to execute a sound clinical strategy.
• Oversee the planning, execution, and reporting of all clinical studies conducted through the Cutera Research Clinic (CRC) and external collaborators (KOLs) and ensure studies track to budget and schedule.
• Integrate scientific knowledge and operational expertise to ensure the translation of clinical research plans into efficiently delivered high-quality studies.
• Serve as Cutera’s clinical subject matter expert by developing a comprehensive understanding of our products' mechanisms of action, recommended treatment settings, clinical endpoints and outcomes, and differentiating features.
• Stay current with new developments in clinical applications, medical device technologies, and competitor products by attending conferences and reviewing clinical research literature.
• Define and drive a comprehensive clinical data dissemination plan to increase market adoption of Cutera’s products through peer-reviewed journal publications, whitepapers, and podium presentations.
• Develop relationships with KOLs to collaborate on clinical studies, data dissemination, and new product development initiatives.
• Build, inspire, and mentor a clinical research team to develop first to market and best-in-class directed energy medical systems for applications in dermatology.
• Serve as an individual contributor as needed to help draft study protocols, monitor clinical studies, analyze study data, implement new clinical techniques, and support study sites.
• Prepare project updates for program reviews with the senior management team.
• Other duties as needed.

Qualifications

Minimum Requirements & Qualifications: 

• BS in engineering or science (MS, PhD, or MD preferred) with at least 10 years of experience in clinical research for medical devices.
• At least 5 years of experience managing clinical research teams with a focus on leading by example.
• Extensive experience leading multiple concurrent clinical studies and collaborating with KOLs to drive publications and podium presentations.
• Demonstrated success in forming strategic partnerships with industry and academic collaborators.
• Basic knowledge of statistical analysis techniques used to design clinical studies and evaluate study results.
• Experience with concepts in one or more of the following areas is preferred: laser-tissue interaction, thermally induced tissue damage, or laser tissue ablation.
• Excellent leadership and communication skills, initiative, and attention to detail and project deadlines.
• Strong understanding of Good Clinical Practice (GCP), industry practices, and regulatory standards.
• Ability to travel as needed (15% - 20%).