Director, Field Clinical and Patient Screening Programs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the Field Clinical function for TMVR clinical studies.

• Create programs, staffing plans, training initiatives, and budgets.

• Lead the process of patient screening and selection for TMVR clinical studies utilizing complex medical imaging and patient-specific analysis.

• Engage in the development and review of clinical research protocols, reports, and statistical analysis plans.

• Act as a senior contact point for Clinical Investigators and site research personnel.

• Establish and monitor standardized operating models, policies, and performance metrics.

• Ensure adherence to FDA, ISO, MDR, and global regulatory standards.

• Collaborate with Clinical Science to ensure alignment with approved clinical strategies and evidence.

• Provide stakeholders with timely updates on clinical data and program developments.

• Present study updates to senior leadership, investigators, and other relevant stakeholders.

• Partner with Clinical Operations, Clinical Science, Quality, Regulatory, Marketing, Medical Affairs, Training, and Commercial teams.

• Offer strategic and operational guidance for field-based clinical teams supporting TMVR programs.

• Facilitate the safe, effective, and compliant execution of clinical trials, training, case management, and patient outcomes.

⛳️ Requirements

• Master's degree in Life Sciences, Engineering, Healthcare, or a related field with at least 7 years of pertinent experience; or a Bachelor's degree in Life Sciences, Engineering, Healthcare, or a related field with a minimum of 9 years of relevant experience.

• Extensive experience supporting complex structural heart clinical programs, including hands-on experience with Transcatheter Mitral Valve Replacement (TMVR) technologies, clinical studies, and procedures.

• Proven experience in building, leading, and scaling field clinical teams for investigational medical device initiatives.

• Expertise in developing organizational capabilities, governance, and standardized operating processes.

• In-depth knowledge of structural heart disease, transcatheter valve therapies, advanced cardiac imaging, and anatomical patient screening and selection.

• Demonstrated ability to maintain relationships with clinical investigators, physician leaders, and research sites.

• Capability to lead cross-functional clinical programs and ensure execution within regulated clinical trial environments.

• Strong strategic leadership, communication, and organizational management skills.

• Ability to influence senior leadership, develop managers, and lead geographically dispersed teams.

• Experience in developing and managing budgets, staffing plans, and operational performance metrics.

• Familiarity with disease states and device utilization.

• Knowledge of FDA, ISO, MDR, and global regulatory requirements.

🏝️ Benefits

• Career development opportunities with an international company.

• Complimentary medical coverage through the Health Investment Plan (HIP) PPO medical plan for eligible employees.

• Exceptional retirement savings plan featuring a significant employer contribution.

• Tuition reimbursement available.

• Freedom 2 Save student debt assistance program.

• FreeU education benefit to support bachelor's degree pursuits.

• Opportunity for growth and learning at a company acclaimed as a great workplace.

• Recognition for diversity, support for working mothers, female executives, and scientists in the workplace.