Director of Clinical Affairs - Ambulatory Monitoring and Diagnostics
$171,000–$273,000 year
On-siteCambridge, Massachusetts, United States or Stamford, Connecticut, United States
Job Summary
Develop and lead the global Clinical Affairs strategy across the Ambulatory Monitoring and Diagnostics portfolio, ensuring clinical evidence generation plans align with product development, regulatory, and business objectives. Architect and oversee clinical evidence programs throughout the product lifecycle, including early feasibility, pivotal, pre-market, and real-world evidence studies. Direct study design, protocol development, endpoint selection, and operational execution to support regulatory submissions and market registrations. Partner cross-functionally with Medical Affairs, R&D, Regulatory, and Marketing to drive alignment and deliver high-quality scientific communications. Lead a high-performing Clinical Affairs organization while serving as the primary external interface with regulatory authorities, investigators, and key opinion leaders. Manage team performance, budgets, and timelines while representing the function in senior leadership and scientific engagements. Requires 10+ years of clinical leadership experience in the medical device industry and 5+ years managing clinical research teams. Full-time office-based role with approximately 20–30% domestic and international travel.
Required Qualifications
- 10+ years of directly related clinical or scientific experience
- leadership or management experience within the medical device industry
- 5+ years managing a clinical research functional team
- proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements
- comprehensive knowledge of clinical research regulations across multiple regions
- FDA and other global regulatory agency medical device regulations
- medical device clinical trial practices
- Good Clinical Practice
- informed consent requirements
- regulatory documentation
- the clinical evidence requirements needed to support regulatory, product development, and commercial objectives
- Bachelor's degree in a scientific discipline
- US work authorization
- no sponsorship for a work-authorized visa
- reside in or within commuting distance to posted locations
- travel domestically and internationally approximately 20–30% of the time
- successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation
Desired Qualifications
- advanced scientific, clinical, or professional degree
- Experience with ambulatory monitoring (Holter and/or Mobile Cardiac Output Telemetry (MCOT))
- remote patient management
- advanced algorithms including AI and/or predictive analytics using electrocardiographic or similar devices
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