JenaValve Technology, Inc.

Outside Sales

• Responsible for Sales and Revenue growth in the assigned territory
• Oversee all commercial activities and transactional requirements
• Work collaboratively with Territory Support Specialist and Regional Therapy Specialist
• Create and develop business plan for assigned accounts
• Manage sales goals, account development, customer engagement, and product awareness
• Coordinate workshops and presentations to disseminate therapy fundamentals
• Provide physicians and medical staff with continuous education and training
• Identify potential product enhancements and new product ideas.

Manager, Territory Sales – Midwest

Clinical Specialist

• Represents JenaValve to medical professionals in product advocacy and education, clinical case support, in-service training, and other related services.
• Delivers technical/clinical training with physicians on-site in hospitals to encourage best practice use of JenaValve devices in the treatment of aortic valve disease.
• Supports JenaValve products currently in development in clinical and marketing contexts.
• Provides workshops and presentations to disseminate TAVR research fundamentals and describing the design and function of JenaValve devices.
• Provides physicians and medical staff with continuous education and technical support related to all aspects of patient outcome, while anticipating and foreseeing obstacles and planning accordingly for smooth execution.
• Advocates with clinicians to uncover other opportunities to expand the use of JenaValve products.
• Interfaces with R&D Engineers to incorporate research developments into training materials.
• Maintains up-to-date knowledge of aortic valve disease and treatment.
• Identifies potential product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of interventional cardiologists.
• Gathers feedback and clinical information from the field and provides input to R&D product development group.
• Develops and maintains professional, high-quality, physician relationships.
• Plans, prepares, and executes/supports TAVR-related research activities with key collaborative centers in aortic valve disease treatment.
• Co-authors publications and generates data to support publications.
• Participates in and builds a product specialist team, to support cases in North America and other regions.
• Reviews and uses 3D reconstruction programs such as 3mensio or Osiris to transform imaging for screening of potential JenaValve TAVI patients.
• Travel 60-70%.

Field Clinical Specialist

Sales

• Achieve or exceed regional sales revenue, case volume, and growth targets
• Develop and execute regional business plans aligned with national strategy
• Drive new account development and expand utilization within existing accounts
• Build and maintain strong relationships with interventional cardiologists, cardiac surgeons, and hospital decision-makers
• Provide field leadership and support during clinical cases
• Partner with Clinical, Professional Education, Finance, HR and Marketing teams
• Recruit, onboard, and develop sales, therapy and clinical teams
• Lead performance through coaching and development
• Collaborate cross-functionally with internal teams
• Maintain forecasting, CRM, and reporting discipline
• Ensure compliance with all policies and regulations
• Travel extensively to support business needs

Director, Regional Sales – East

Compliance

• Support audit planning and execution for internal and investigational site audits
• Enter, track, and monitor CAPAs, non-conformances, and audit corrective actions
• Support vendor qualification activities for CROs, core labs, and other clinical service providers
• Maintain compliance metrics dashboards
• Support continuous process improvement and other clinical affairs deliverables as needed

Clinical Compliance Specialist

• Develop and execute a risk-based audit program covering internal processes and investigational sites; author audit plans and reports, and lead inspection readiness activities including TMF health assessments and mock inspections; partner with Quality on audit scheduling, joint audit conduct, and preparation for regulatory agency inspections (FDA, EU Notified Body) and corporate quality audits.
• Own CAPA and non-conformance management for the department; serve as the central accountability point for CAPA status, effectiveness checks, and closure, coordinating with functional owners across sub-teams; maintain alignment with Quality on CAPA creation, classification, and tracking to ensure consistency with enterprise quality system requirements.
• Own the vendor qualification and ongoing quality oversight program for CROs, core labs, EDC vendors, and other clinical service providers; issue and track SCARs, evaluate corrective action responses, and escalate unresolved quality issues with contract implications to leadership.
• Lead the Clinical Affairs procedure lifecycle, including authoring, reviewing, and approving SOPs and work instructions; coordinate the annual review cycle across sub-departments; maintain the controlled document management system in alignment with enterprise quality system standards, serving as the primary liaison to Quality on document control processes and procedure governance.
• Monitor and communicate regulatory developments and GCP guidance updates (FDA, ICH, EU CTR); evaluate impact on operations and procedures and serve as the department’s internal GCP compliance subject matter expert.
• Design and deliver the Clinical Affairs internal training program, including GCP onboarding, procedural updates, and audit corrective action training; maintain training matrices and completion records for all department personnel.
• Directly manage and develop the Specialist, Clinical Compliance; provide day-to-day direction, performance feedback, and professional development support.
• Support continuous process improvement and PMA/IDE activities as they relate to compliance, study conduct quality, and regulatory commitments; complete training for internal SOPs and maintain current regulatory knowledge.

Manager, Territory Sales – Midwest

Field Clinical Specialist

Director, Regional Sales – East

Clinical Compliance Specialist

Senior Manager, Clinical Compliance