Director of Clinical Affairs - Ambulatory Monitoring and Diagnostics

Philips•Stamford, MA

22d•Hybrid

About The Position

The Director, Clinical Affairs of Ambulatory Monitoring and Diagnostics (AM&D) leads the vision and execution of clinical evidence strategies that support business growth, product innovation, regulatory success, and clinical adoption across the Cardiovascular portfolio. This role partners cross-functionally with Medical Affairs, R&D, Regulatory, Marketing, Quality, and commercial leadership and other functions to design and deliver high-impact clinical evidence programs aligned with business priorities, unmet clinical needs, and evolving industry standards.

Requirements

10+ years of directly related clinical or scientific experience, including leadership or management experience within the medical device industry
5+ years managing a clinical research functional team with a 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, and the clinical evidence requirements needed to support regulatory, product development, and commercial objectives.
Bachelor’s degree in a scientific discipline
Ability to represent Philips professionally in scientific, regulatory, clinical, and business forums
Ability to travel domestically and internationally approximately 20–30% of the time.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Must reside in or within commuting distance to posted locations.

Nice To Haves

An advanced scientific, clinical, or professional degree is preferred.
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

Responsibilities

Develop and lead the global Clinical Affairs strategy across the AM&D portfolio, ensuring clinical evidence generation plans are aligned with product development, regulatory, commercial, health economics, and business objectives.
Partner closely with Marketing, Regulatory, Quality, R&D, Medical Affairs, and executive leadership to establish priorities and drive cross-functional alignment.
Architect and oversee clinical evidence programs across the product lifecycle, including early feasibility, pivotal, pre-market, post-market, registry, and real-world evidence studies.
Direct study design, protocol development, endpoint selection, statistical strategy, operational execution, and evidence dissemination to support innovation, clinical adoption, and regulatory success.
Build and deliver high-quality clinical evidence and scientific communications that support regulatory submissions, market registrations, clinical evaluations, product claims, publication strategies, lifecycle management, and global evidence dissemination.
Ensure all clinical programs are scientifically rigorous, operationally effective, and compliant with applicable regulations, standards, and company policies.
Provide strategic clinical leadership throughout product development and commercialization, including clinical input into risk management, design controls, preclinical and clinical study strategies, new product development processes, and design history documentation.
Serve as the primary Clinical Affairs representative in governance forums, core teams, and key business decision-making activities.
Lead and develop a high-performing Clinical Affairs organization while serving as a key external clinical interface with regulatory authorities, investigators, key opinion leaders, professional societies, and scientific stakeholders.
Oversee team performance, budgets, timelines, and quality objectives, while supporting the representation of the business and Clinical Affairs function in senior leadership, regulatory, and external scientific engagements.