Clinical Development Senior Specialist

Freddie Mac; United States; Remote; USD 155,000 - 185,000; Full time

Job summary

An innovative company dedicated to improving lives through cutting-edge therapies is seeking a skilled professional to lead case preparation and support physicians during TMVR procedures. This role involves collaborating with various teams to enhance training tools and refine procedures, ensuring the highest level of care in the clinical environment. With a focus on cardiovascular health and a commitment to excellence, this position offers a unique opportunity to make a significant impact in the medical device industry. If you are passionate about advancing healthcare and have the expertise to drive success, this role is for you.

Qualifications

• 3+ years in the medical device industry with experience in mitral repair/replacement.
• Strong understanding of cardiac anatomy and imaging interpretation.

Responsibilities

• Lead case preparation and proctor physicians during TMVR procedures.
• Provide clinical training for cardiologists and refine implant procedures.

Skills

Cardiovascular Anatomy Knowledge

Interventional Procedures

Imaging Interpretation Skills

Project Management

Communication Skills

Customer Service Orientation

Microsoft Office Suite Proficiency

Education

Bachelor's Degree in Biology or Related Field

Registered Diagnostic Cardiac Sonographer (RDCS)

Job description

Job Type
Full-time

Description
ABOUT 4C MEDICAL TECHNOLOGIES:
We are a small, well-funded team dedicated to developing innovative therapies that improve and save lives. Located in Maple Grove, MN, 4C Medical Technologies is working on the first Mitral Regurgitation therapy to expand treatment options and streamline procedures. Our Alta Valve is currently in the clinical trial phase for FDA approval.

POSITION SCOPE AND PURPOSE:
Reporting to the VP of Therapy Development, this role leads case preparation and proctors physicians implanting the AltaValve TMVR procedures, focusing on procedural imaging. Collaborates with internal teams to develop training tools and refine procedures.

ROLE RESPONSIBILITIES:

1. Partner with R&D, Clinical Operations, and other teams to prepare for TMVR procedures, including organizing patient-specific presentations, performing bench deployments in 3D printed anatomies, and identifying deployment strategies.
2. Provide clinical and technical training for cardiologists, surgeons, and staff on structural heart products.
3. Proctor physicians during AltaValve implantations and intraoperative imaging.
4. Lead post-implant case reviews, disseminate learnings, and follow up on patient management and potential issues.
5. Refine implant procedures and training materials in collaboration with R&D.
6. Assist in developing recruitment tools and identify potential candidates for clinical studies.
7. Identify recruitment challenges and develop solutions to improve trial performance regionally and nationally.

Requirements

Education:

• Bachelor's degree in biology, physical sciences, nursing, or related field preferred.
• Registered Diagnostic Cardiac Sonographer (RDCS) or similar credential preferred.

Experience:

• At least 3 years in the medical device industry.
• Experience with transcatheter mitral repair/replacement or LAA closure.
• Knowledge of cardiac and vascular anatomy, physiology, and pathology.
• Experience in teaching and medical personnel education.
• Imaging interpretation skills (TTE, TEE, CT, angiograms).

Knowledge, Skills, and Abilities:

• Strong understanding of cardiovascular anatomy and interventional procedures.
• Knowledge of mitral procedures, terminology, and device instructions for use.
• Familiarity with FDA regulations and clinical trial conduct.
• Excellent communication and interpersonal skills.
• Customer service orientation.
• Project management skills.
• Proficiency in Microsoft Office Suite.
• Organizational skills and ability to manage multiple priorities.
• Decision-making skills under pressure.
• Willingness to travel domestically and internationally.

Salary Range: $155,000 to $185,000 annually.