This person will develop, lead, & help drive Casanas clinical studies strategy. Reporting to the Chief Research Officer, the Director of Clinical Studies will help provide vision, leadership, strategy, & scientific approach for the companys clinical studies programs, as well as participate in strategic aspects of medical device development. 

This position can have a hybrid schedule & can be based in either Rochester, NY or Boston, MA.

Key Responsibilities

• Use medical & clinical expertise in defining, designing, implementing, investigating, & managing clinical studies in a team setting
• Write & review study protocols & outlines
• Interact directly with institutions & investigators, execute clinical research initiatives & ensure alignment with strategic goals
• Write and/or review clinical sections of clinical trial reports, statistical reports, & responses to Regulatory questions
• Act as the Principal Investigator for studies & protocols
• Assure timely initiation of studies; act as liaison with Regulatory, project teams, & investigators
• Ensure operational aspects of the studies are being conducted in accordance with all relevant ethical & government standards, GCPs, & Casana Standard Operating Procedures
• Support recruitment & retention activities
• Provide medical & scientific support in other aspects of company activities
• Assist in developing clinical program timelines, budgets, & strategies

Required Skills & Experience

• PhD in science or engineering and/or M.D.
• Minimum of 10 years of relevant professional experience.
• Minimum of 5 years of management-level experience.
• Experience in developing, planning, directing, designing, & implementing all phases of clinical studies in the medical device space.
• Prior clinical research or related experience with medical devices.
• A robust history of running clinical studies or clinical trials as the Principal Investigator.
• Hands-on, proven ability to work in a small environment, with the ability to manage & outsource work as needed.
• Ability to work in a fast-paced team, & capable of handling multiple projects simultaneously.
• Strong organizational skills.
• Excellent communications skills: Technical writing/presentation, verbal, interpersonal.
• Strong analytical & problem-solving skills with the ability to seamlessly integrate theory with empirical data.
• Exceptional attention to detail in calculations, hands-on experimentation, & documentation.

Company Description

Casana is revolutionizing home healthcare by creating clinical-grade technology that unobtrusively checks a persons health. Backed by a top-ranked VC & led by a CEO who founded & led a tech unicorn to a successful IPO, Casana is designing & building the home-health platform of the future. We are seeking bright, driven candidates to join our team.

Casana creates technologies that enable healthcare in the home. Casana has created a toilet seat-based cardiovascular monitoring system that is self-contained, cloud-connected, & installs directly on a standard toilet. The Heart Seat requires no user behavior change & is capable of capturing multiple key clinically relevant measurements, including heart rate, blood pressure, blood oxygenation, & cardiac output. 

We offer competitive salaries, excellent benefits, unlimited paid time off, & an opportunity to work in a fast-paced, purpose-driven, collaborative environment.