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Director, Clinical Affairs – Coronary/Vascular
PhilipsPhilips clinical affairs director leading coronary and vascular device evidence strategies. Driving clinical programs, regulatory submissions, product innovation, and commercialization across the cardiovascular portfolio.
Posted 8/4/2026full-timePlymouth • California, Colorado, Massachusetts, Minnesota • 🇺🇸 United StatesLead💰 $171,000 - $306,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Clinical Affairs strategy, clinical evidence generation, and regulatory compliance within the medical device industry. Proven ability to lead cross-functional teams and manage complex clinical programs effectively.
Highest-signal resume keywords
Clinical Affairs Strategy DevelopmentCoronary Clinical Research ManagementRegulatory Compliance KnowledgeClinical Evidence GenerationLeadership in Clinical Research
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research RegulationsFDA Medical Device RegulationsGood Clinical PracticeClinical Trial PracticesStatistical StrategyProtocol DevelopmentEvidence DisseminationOperational ExecutionRisk ManagementDesign History Documentation
Soft Skills
Effective CommunicationRelationship BuildingInfluencing SkillsTeam ManagementCross-Functional Collaboration
Industry Keywords
Medical Device IndustryClinical Evidence RequirementsInformed Consent RequirementsRegulatory DocumentationProduct DevelopmentMarket RegistrationsClinical EvaluationsGlobal Evidence DisseminationExecutive Leadership EngagementComplex Matrixed Environment
About the role
Key responsibilities & impact- Develop and lead the global Clinical Affairs strategy across the coronary and vascular portfolio
- Align clinical evidence generation plans with product development, regulatory, commercial, health economics, and business objectives
- Partner 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
- Build and deliver clinical evidence and scientific communications supporting regulatory submissions, market registrations, clinical evaluations, product claims, publications, lifecycle management, and global evidence dissemination
- Ensure clinical programs are scientifically rigorous, operationally effective, and compliant with regulations, standards, and company policies
- Provide strategic clinical leadership throughout product development and commercialization
- Contribute clinical input to risk management, design controls, preclinical and clinical study strategies, new product development, and design history documentation
- Represent Clinical Affairs in governance forums, core teams, and business decision-making activities
- Lead and develop a high-performing Clinical Affairs organization
- Serve as the primary external clinical interface with regulatory authorities, investigators, key opinion leaders, professional societies, and scientific stakeholders
- Oversee team performance, budgets, timelines, and quality objectives
- Represent the business and Clinical Affairs function in senior leadership, regulatory, and external scientific engagements
- Travel domestically and internationally approximately 20–30% of the time
Requirements
What you’ll need- 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
- Experience with coronary clinical research is required
- Comprehensive knowledge of clinical research regulations across multiple regions
- Knowledge of FDA medical device regulations
- Knowledge of medical device clinical trial practices
- Knowledge of Good Clinical Practice
- Knowledge of informed consent requirements
- Knowledge of regulatory documentation
- Knowledge of clinical evidence requirements supporting regulatory, product development, and commercial objectives
- Bachelor’s degree in a scientific discipline
- Ability to build strong internal and external relationships and influence through direct and indirect reporting lines
- Ability to communicate effectively with technical, clinical, regulatory, executive, and external audiences
- Ability to manage multiple studies, team priorities, and company initiatives in a complex matrixed environment
- Ability to represent Philips professionally in scientific, regulatory, clinical, and business forums
- US work authorization required; candidates requiring current or future visa sponsorship will not be considered
- Must reside in or within commuting distance to a posted location
- Ability to meet minimum physical, cognitive, and environmental job requirements with or without accommodation
Benefits
Comp & perks- Generous PTO
- 401k with up to 7% match
- HSA with company contribution
- Stock purchase plan
- Education reimbursement
- Annual incentive bonus may be offered
- Sales commission may be offered
- Long-term incentives may be offered
- Equal employment and advancement opportunities
- Reasonable accommodations for individuals protected by applicable laws