Reports to: Head of Clinical
Workplace Type: Hybrid/Onsite in Santa Cruz, CA
Type: Full-time
About Us:
At Capstan Medical, we are driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we have pioneered a patient-optimized approach to repair and replace heart valves.
Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients with a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
Capstan Medical is uniquely positioned in Santa Cruz, CA; this gives us access to the amazing technical talent of the Bay Area but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Come join us and become part of a team revolutionizing heart valve treatment!
Description:
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.
General Description of 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.
Qualifications and Skills:
- 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.
Why Join Us:
- 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!
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.