Senior Director, Clinical Affairs
Core
Lead global clinical studies and evidence generation for cardiac surgical devices to optimize patient outcomes and support new product development.
Role type
Senior Director, Clinical Affairs (Strategic Leadership)
Builds
Global clinical trial portfolios and clinical evidence packages for Class II & III medical devices
Domain
Medical Devices / Cardiac Surgery / Clinical Research
Required skills
Clinical strategy, People management, Global trial leadership, Regulatory compliance, Stakeholder management, Financial acumen
Preferred skills
Heart valve/coronary disease expertise, Pivotal trial management, Cross-functional system implementation, Biostatistical methods
Technologies
Clinical trial management systems, Regulatory submission platforms
Responsibilities
Direct clinical activities including planning, staffing, and budgeting for global studies; Oversee trial management and CRO staff; Advise executive leadership on clinical strategy; Mitigate risk in complex projects; Ensure on-time execution of trials per GCP; Develop KOL relationships; Lead scientific communication for regulatory submissions.
Seniority
Senior Director, Strategic Leadership & People Management