Director of Clinical Affairs

This person will develop, lead, and help drive Casana’s clinical affairs strategy. Reporting to the Chief Research Officer, the Director of Clinical Affairs will help provide vision, leadership, strategy, and scientific approach for the company’s clinical studies programs, as well as participate in strategic aspects of medical device development. 

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

Key Responsibilities

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

Required Skills and Experience

• PhD in science or engineering and/or M.D. preferred.
• Minimum of 10 years of relevant professional experience.
• Minimum of 5 years of management-level experience.
• Experience in developing, planning, directing, designing, and 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 and outsource work as needed.
• Ability to work in a fast-paced team, and capable of handling multiple projects simultaneously.
• Strong organizational skills.
• Excellent communications skills: Technical writing/presentation, verbal, interpersonal.
• Strong analytical and problem-solving skills with the ability to seamlessly integrate theory with empirical data.
• Exceptional attention to detail in calculations, hands-on experimentation, and documentation.

Company Description

Casana solves the healthcare industry’s biggest challenge - adherence. The Heart Seat™, a toilet seat with a built-in cardiovascular monitoring system, is self-contained, cloud-connected, and installs directly on the standard toilet already in your home. The best part? All you need to do is sit. 

This unique technology captures multiple key measurements, including heart rate, blood pressure, blood oxygenation, and cardiac output, enabling healthcare providers to be on the frontlines of preventative healthcare for chronic diseases. Backed by best-in-class VC’s and led by a CEO who founded and exited a tech unicorn to a successful IPO, Casana is innovating the frontier home-health platform built for ease.

Compensation:

Base salary range of $175,000 - $195,000 per year. Exact compensation may vary based on skills, experience and location. Our compensation consists of base salary and equity as well as a generous benefits package. 

Casana provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.