The Mullings Group · 20 hours ago
Senior Director of Clinical Affairs
The Mullings Group is seeking a Sr. Director of Clinical Affairs to lead their clinical strategy in the Structural Heart space. This role involves developing and executing clinical strategies, overseeing clinical trials, and collaborating with key healthcare institutions to bring innovative solutions to patients.
Responsibilities
Drive patient enrollment across 3+ active US sites
Manage and oversee US CRO and European CRO relationships
Execute site activation, training, and physician relationship management
Support the European first clinical experience and ongoing EU expansion
Attend cases, troubleshoot site issues, and maintain close site relationships
Collaborate on FDA interactions and design feedback sessions
Support pivotal trial planning and ASD Seal EFS preparation
Ensure GCP compliance and regulatory readiness across all clinical activities
Own clinical timelines, budgets, and resource allocation in coordination with CROs
Report clinical progress to CEO, Board, and strategic partners
Manage vendor relationships and site contracts
Qualification
Required
8-12+ years in medical device clinical affairs with cardiovascular/structural heart focus
Hands-on experience managing 2-3 concurrent multi-site clinical trials
Proven track record with CRO management and oversight
FDA regulatory pathway experience (EFS, pivotal trials, PMA submissions)
Strong site activation, enrollment execution, and physician relationship skills
Comfortable with startup ambiguity and rapid decision-making
Company
The Mullings Group
The Mullings Group is a search firm specializing in the medical device market.
Funding
Current Stage
Early StageRecent News
The Mullings Group
2025-08-28
Canada NewsWire
2022-12-23
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