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 trials

• Create programs, staffing strategies, training for teams and clinical sites, along with budget plans

• Direct the Patient Screening and Selection process for TMVR clinical trials

• Generate patient-specific analyses for selecting candidates for TMVR studies using intricate medical imaging data

• Facilitate trial enrollment by providing materials for patient screening and selection

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

• Act as a primary contact for Clinical Investigators and site research personnel

• Set up and oversee standardized operating models, policies, and performance indicators

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

• Work collaboratively with Clinical Science to ensure alignment with approved clinical strategies and evidence

• Deliver accurate, timely, and consistent clinical data and program updates to stakeholders

• Present study updates to senior leadership, investigators, and key stakeholders

• Provide strategic and operational guidance for field-based clinical teams supporting TMVR initiatives

• Collaborate with Clinical Operations, Clinical Science, Quality, Regulatory, Marketing, Medical Affairs, Training, and Commercial departments

• Make recommendations regarding staffing, budgeting, and policies

⛳️ Requirements

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

• Extensive experience in supporting complex structural heart clinical programs

• Direct experience with Transcatheter Mitral Valve Replacement (TMVR) technologies, clinical studies, and procedures

• Proven experience in building, leading, and expanding field clinical teams for investigational medical device programs

• Expertise in developing organizational competencies, governance, and standardized operating processes

• Strong understanding 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 navigate complex clinical decisions, investigator expectations, and enrollment challenges

• Ability to lead cross-functional clinical programs and ensure effective execution in regulated clinical trial settings

• Strong strategic leadership, communication, and organizational management capabilities

• Ability to influence senior leadership, develop managers, and lead teams dispersed across various locations

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

• Knowledge of disease states and device utilization

• Willingness and capability to travel 50% of the time

🏝️ Benefits

• Opportunities for career development with an international company

• Complimentary medical coverage in the Health Investment Plan (HIP) PPO medical plan (eligibility in the following calendar year)

• Exceptional retirement savings plan with a substantial employer contribution

• Tuition reimbursement program

• Freedom 2 Save student debt initiative

• FreeU education benefit

• Opportunity to obtain a bachelor’s degree through an affordable education benefit

• Recognized as a top employer and one of the most admired companies

• Acknowledged among the best large companies to work for and top workplaces for diversity, working mothers, female executives, and scientists