Director of Clinical Affairs – Ambulatory Monitoring & Diagnostics
philips · Cambridge (US)
Job description
About the role
The Director of Clinical Affairs for Ambulatory Monitoring & Diagnostics will shape and execute the clinical evidence strategy for Philips’ cardiovascular portfolio. This senior leader partners with R&D, regulatory, marketing, quality and commercial teams to deliver high‑impact studies that drive product innovation, regulatory approval and market adoption.
Key responsibilities
- Develop and lead the global Clinical Affairs strategy across the AM&D portfolio, aligning evidence generation with product development, regulatory and commercial goals.
- Architect and oversee clinical evidence programs throughout the product lifecycle, including feasibility, pivotal, pre‑market, post‑market, registry and real‑world evidence studies.
- Direct study design, protocol development, endpoint selection, statistical strategy and operational execution to support innovation and regulatory success.
- Provide strategic clinical leadership for risk management, design controls, pre‑clinical and clinical study strategies, and serve as the primary Clinical Affairs representative in governance forums.
- Lead, mentor and manage a high‑performing Clinical Affairs organization, overseeing budgets, timelines and quality objectives.
Required profile
- 10+ years of clinical or scientific experience in the medical device industry, including 5+ years managing a clinical research team.
- Comprehensive knowledge of global clinical research regulations, FDA requirements, Good Clinical Practice and medical device trial standards.
- Bachelor’s degree in a scientific discipline; an advanced degree is preferred.
- Proven ability to influence cross‑functional partners and communicate with technical, regulatory and executive audiences.
Required skills
- Experience with ambulatory monitoring technologies such as Holter and Mobile Cardiac Output Telemetry (MCOT).
- Expertise in AI‑driven predictive analytics applied to electrocardiographic data.
- Strong background in clinical trial design, statistical strategy and real‑world evidence generation.
What we offer
- Competitive salary range of $192,000 – $306,000 per year, plus annual incentive bonus and long‑term incentives.
- Comprehensive total rewards package including generous PTO, 401(k) match up to 7 %, HSA contributions, stock purchase plan and education reimbursement.
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Published 2 weeks ago
Expires 1 month from now
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philips
Cambridge (US)
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