Head of Clinical Applications

Capstan Medical, Inc. • Santa Cruz, CA

22d • Hybrid

About The Position

We are seeking a Head of Clinical Applications to provide leadership, guidance, supervision, and growth to the Clinical Applications team while establishing positive partnerships with external clinical partners. This position will create the infrastructure for excellence in case support and accurate, efficient patient screening. This role is responsible for designing appropriate organizational team structures; work assignments; training plans; tracking progress for continuous improvement; and regular reporting to internal stakeholders. The Head of Clinical Applications will partner extensively across the organization to ensure success in our upcoming clinical trials. This role will collaborate closely cross-functionally to ensure that site expectations, clinical standards, and compliance requirements are met in the course of creating, maintaining, and improving department infrastructure.

Requirements

• At least 10 years in medical device clinical applications roles at a leadership level, with a proven track record of successfully establishing, designing, managing and executing clinical application requirements.
• Experience supporting mitral and/or tricuspid clinical studies and deep knowledge of imaging/software used for case screening and collaboration.
• Bachelor’s degree; an advanced healthcare degree is preferred.
• Exceptional understanding of clinical study and clinical application workflow principles and concepts and how they are integrated into the Capstan product, clinical, and quality systems.
• Strong interpersonal and communication skills and the ability to work effectively across an organization.
• Ability to strategically develop and maintain systems and procedures. Skill in organizing resources and establishing priorities.
• Ability to train clinicians and/or other professional staff for patient screening, planning, and support.
• Ability to apply critical thinking to business and technical problems. Strong business acumen and contract negotiating skills.
• Exceptional project management, strategic, and written/verbal communication skills.
• Skilled in the use of computers, Microsoft Suite of products.
• Strong work ethic to meet tight timelines and manage multiple projects with a problem solving, collaborative mindset.
• Ability to work onsite in Santa Cruz as needed.
• Ability to work outside the Monday-Friday, 9am-5pm schedule, especially to account for travel and different geographies.

Responsibilities

• Partners closely with Clinical Affairs team to ensure success in upcoming pre-pivotal and pivotal clinical trials. This role will lead the team responsible for the patient screening and clinical case support.
• Provides leadership and coordination of work to the Clinical Application team including recruiting, training and mentorship of the patient screening and case support team.
• Responsible for building the Clinical Applications processes and systems
• Collaborates closely with the internal cross-functional teams and external clinical partners to successfully complete our clinical cases on tight timelines. Identifies and manages the relationship with key clinical application suppliers and partners. Works closely with suppliers to ensure successful performance of products, including risk mitigation strategies and troubleshooting.
• Build strong relationships with our investigators and clinical sites
• Gather insights from our users and clinical institutions
• Develops clinical application strategies in collaboration with leaders in the organization and other Capstan Medical cross-functional teams. Develops, analyzes, and reports metrics associated with clinical application performance.
• Acts as a business relationship manager among stakeholders to provide project definition, process leadership, timeframe, cost, delivery, issue resolution, risk mitigation, and communicate status.
• Manage clinical applications budgets, timelines, and resources.
• Monitor industry trends to identify new clinical application needs and technology changes.
• Other duties as assigned.

Benefits

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager