Principal Field Clinical Lead

This is a fully remote position, open to applicants in Ohio, +2 more states.

📋 Description

• Oversee and cultivate strategic partnerships with clinical trial sites, investigators, and research teams.

• Assist in the execution of clinical trials from the identification and qualification of sites through activation, enrollment, monitoring, and closeout.

• Work alongside investigators and site personnel to enhance screening and meet enrollment goals.

• Recognize enrollment obstacles and implement solutions for recruitment and study performance.

• Stay informed about site capabilities, research infrastructure, and investigator interests.

• Facilitate effective communication between clinical sites and Abbott teams.

• Act as a subject matter expert for Abbott's TAVI clinical programs and investigational technologies.

• Provide procedural guidance and technical support during investigational TAVI procedures.

• Assist with procedural planning, device usage, and adherence to study protocols.

• Collaborate with commercial field teams when additional procedural expertise is necessary.

• Create and deliver educational content for physicians, research coordinators, physician assistants, nurses, and Cath Lab personnel.

• Train healthcare professionals on investigational devices, clinical protocols, procedural best practices, and study requirements.

• Develop educational materials for investigator meetings, conferences, physician training programs, and internal initiatives.

• Communicate clinical data, trial objectives, and evidence-based recommendations.

• Partner with Global Clinical Affairs and Medical Affairs on research initiatives.

• Support the design of studies, enrollment strategies, trial performance, and diverse patient enrollment.

• Collaborate with Engineering, Clinical Affairs, and Product Development on next-generation TAVI platforms.

• Provide clinical insights for product innovation and design.

• Participate in pre-clinical and clinical evaluations, including First-in-Human, Early Feasibility, and IDE trials.

• Mentor and develop less-experienced Field Clinical Specialists.

• Lead cross-functional projects and assist with onboarding, coaching, and development.

• Identify opportunities for operational improvements and process standardization.

• Conduct activities in compliance with FDA regulations, GCP guidelines, company policies, quality requirements, and study protocols.

• Ensure timely and accurate documentation and communication of clinical activities.

• Build collaborative relationships with customers, physicians, investigators, and internal partners.

⛳️ Requirements

• Associate degree with over 13 years of relevant experience, or Bachelor’s degree with at least 10 years of relevant experience, or Master’s degree or advanced degree with a minimum of 5 years of relevant experience.

• Background in Biological Sciences, Health Sciences, Nursing, Biomedical Engineering, Clinical Research, or another related healthcare or scientific discipline.

• Significant experience in supporting implants and procedures involving complex transcatheter valve technologies.

• Extensive experience within a structural heart or transcatheter valve medical device organization.

• Prior experience in providing training to physicians and healthcare staff on advanced cardiovascular procedures.

• At least 4 years of clinical research experience, preferably in Field Clinical Affairs or Medical Device Clinical Operations.

• Strong understanding of TAVI/TAVR procedures, clinical trial execution, Cath Lab workflows, Hybrid Operating Room settings, and therapies for structural heart disease.

• Experience in managing physician relationships and supporting high-volume clinical centers.

• Profound clinical and procedural knowledge of structural heart therapies.

• Exceptional presentation and training skills for physicians.

• Strong leadership and mentoring abilities.

• Capacity to influence without direct authority.

• Excellent written and verbal communication skills.

• Strong organizational and project management capabilities.

• Ability to work independently while effectively collaborating across cross-functional teams.

• Proficient at managing multiple priorities in a fast-paced work environment.

• High attention to detail and a commitment to quality.

• Ability to establish credibility and trust with physicians, investigators, and internal stakeholders.

• Willingness to travel approximately 50% to 75%, including overnight travel, both domestically and internationally.

• Flexibility to accommodate physician and customer needs outside standard business hours, including occasional evenings and weekends.

• Maintain necessary certifications and training for designated product lines and study processes.

🏝️ Benefits

• Opportunities for career advancement within an international company.

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

• Excellent retirement savings plan with a substantial employer contribution.

• Tuition reimbursement options available.

• Freedom 2 Save program for student debt assistance.

• FreeU educational benefit aiding in the pursuit of a bachelor’s degree.

• Comprehensive training and career development through onboarding programs.

• Tuition assistance for further education.

• Competitive compensation package along with incentives.

• Comprehensive medical, dental, and vision plans.

• Wellness and occupational health programs.

• Paid time off for personal use.

• 401(k) retirement savings plan with a generous company match.