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Posted: 10/20/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading clinical functions for Transcatheter Mitral Valve Replacement (TMVR) studies, ensuring compliance with FDA, ISO, and MDR regulations while effectively managing budgets, staffing, and operational performance metrics.
Highest-signal resume keywords
TMVR Clinical Studies LeadershipComplex Medical Imaging ExpertiseRegulatory Compliance KnowledgeCross-Functional Team LeadershipBudget and Staffing Management
About the role
Key responsibilities & impact- Lead the Field Clinical function for TMVR clinical studies
- Develop programs, staffing plans, training programs, and budgets
- Lead patient screening and selection for TMVR clinical studies using complex medical imaging and patient-specific analysis
- Participate in developing and reviewing clinical research protocols, reports, and statistical analysis plans
- Serve as a senior point of contact for Clinical Investigators and site research staff
- Establish and monitor standardized operating models, policies, and performance metrics
- Ensure compliance with FDA, ISO, MDR, and global regulatory requirements
- Collaborate with Clinical Science to align with approved clinical strategies and evidence
- Provide timely clinical data and program updates to stakeholders
- Present study updates to senior leadership, investigators, and other stakeholders
- Partner with Clinical Operations, Clinical Science, Quality, Regulatory, Marketing, Medical Affairs, Training, and Commercial functions
- Provide strategic and operational leadership for field-based clinical teams supporting TMVR programs
- Support safe, effective, and compliant clinical trial execution, training, case conduct, and patient outcomes
Requirements
What you’ll need- Master's degree in Life Sciences, Engineering, Healthcare, or a related field with a minimum of 7 years of relevant experience; or Bachelor's degree in Life Sciences, Engineering, Healthcare, or a related field with a minimum of 9 years of relevant experience
- Significant experience supporting complex structural heart clinical programs, including direct experience with Transcatheter Mitral Valve Replacement (TMVR) technologies, clinical studies, and procedures
- Experience building, leading, and scaling field clinical teams supporting investigational medical device programs
- Experience developing organizational capabilities, governance, and standardized operating processes
- Strong understanding of structural heart disease, transcatheter valve therapies, advanced cardiac imaging, and anatomical patient screening and selection
- Proven ability to maintain relationships with clinical investigators, physician leaders, and research sites
- Ability to lead cross-functional clinical programs and ensure execution in regulated clinical trial environments
- Strategic leadership, communication, and organizational management skills
- Ability to influence senior leadership, develop managers, and lead geographically dispersed teams
- Experience developing and managing budgets, staffing plans, and operational performance metrics
- Knowledge of disease state and device usage
- Knowledge of FDA, ISO, MDR, and global regulatory requirements
Benefits
Comp & perks- Career development with an international company
- Free medical coverage through the Health Investment Plan (HIP) PPO medical plan for qualifying employees
- Excellent retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit toward a bachelor’s degree
- Opportunity to grow and learn at a company recognized as a great place to work
- Diversity, working mothers, female executives, and scientists workplace recognition
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 Protocol DevelopmentStatistical Analysis PlansPatient Screening and SelectionAdvanced Cardiac ImagingOrganizational Capability DevelopmentPerformance Metrics EstablishmentClinical Trial ExecutionTranscatheter Valve Therapies KnowledgeInvestigational Medical Device ProgramsStructural Heart Disease Understanding
Soft Skills
Strategic LeadershipCommunication SkillsOrganizational ManagementRelationship BuildingInfluencing Senior Leadership
Industry Keywords
FDAISOMDRClinical InvestigatorsClinical OperationsClinical ScienceMedical AffairsQuality AssuranceHealthcareLife Sciences