Jill Paynter

About Jill Paynter

I am a clinical affairs leader with deep expertise in heart failure and LVAD clinical trials, leading high-stakes, multi-site IDE and PAS studies with precision to drive FDA approvals, protocol innovation, and field-to-scientist operational excellence. I bridge clinical operations, regulatory strategy, and commercial adoption while mentoring teams to operate at a regional director level. My focus is on accelerating patient access, ensuring data integrity, and creating repeatable processes that set new standards for trial execution.As a strategic yet hands-on leader, I thrive in complex, cross-functional environments. I directly interface with regulatory bodies, CROs, and principal investigators, while designing and deploying clinical reimbursement templates, study activation improvements, and patient referral programs. I maintain credibility in the field by staying close to site operations, transforming insights into actionable strategies, and driving measurable outcomes across 50+ sites and 7+ states: Led TEAM-HF IDE (850 patients, 75 sites) to on-time activation and IP resolution with UC Regents Directed GUIDE-HF IDE/RWE (3,600 patients, 145 sites), creating standardized field-to-contracting protocols and clinical reimbursement kits Championed ARIES HM3 IDE (628 patients, 50 sites) with FDA label change and global site onboarding Managed CentriMag FTW PAS Registry (32 patients, 15 sites) ensuring PMA compliance and high-value site optimization Executed CardioMEMS PAS Registry (1,200 patients, 150 sites) with accelerated enrollment and post-publication data disseminationI welcome opportunities to drive clinical strategy, trial innovation, and patient-centric outcomes in heart failure, medical device, and life-sciences organizations. If you’re looking for a leader who combines operational rigor with strategic vision, let’s connect. Email: p••••••••@gmail.com : Clinical Trial Leadership | IDE/PAS Execution | FDA Regulatory Strategy | Protocol Development | Multicenter Site Activation | Reimbursement & Access Strategy | Data Integrity & Analysis | CRO Oversight | Clinical Proctoring | Strategic Trial Planning | Risk & Compliance Oversight | Team Mentorship

Experience

1. Principal Field Clinical Specialist

   雅培

   Jan 2015 — Present · US

   Equipped with extensive expertise in global heart failure and LVAD clinical trials, I drive end-to-end study execution, protocol optimization, and cross-functional collaboration, ensuring regulatory compliance, seamless site onboarding, and high-quality data collection. I bridge field operations with R&D, medical affairs, and commercial teams, mentoring colleagues, proctoring physicians, and providing technical guidance to accelerate trial success and advance patient-centered outcomes. Active member of Abbott’s Heart Failure Council and Women Leaders network, shaping strategic initiatives and field excellence. TEAM-HF IDE: Directed 850 patients across 75 sites, resolving IP impasses and implementing referral programs for timely enrollment. ARIES HM3 IDE: Led 628 patients at 50 sites, influencing protocol design, coordinating blinded drug logistics, and supporting FDA label change with publications. GUIDE-HF IDE: Managed 3,600 patients across 145 sites, standardizing workflows, field-to-contracting protocols, and reimbursement kits for global compliance. CentriMag FTW PAS Registry: Optimized 32 patients across 15 sites, identifying high-value sites, closing non-performing locations, and ensuring PMA compliance. Calibrated Therapeutics Phase 2: Engineered 24-patient feasibility study, managing protocol design, vendor operations, and publication-ready data analysis. Additional Studies: ARTISAN, CERENO, INTELLECT II, Prevent II PMA, MOMENTUM 3 IDE CAP, CardioMEMS PAS: led site execution, CRO coordination, and cross-functional field support across multiple territories.

Education

• West Texas A&M University College of Business

  Master of Business Administration - MBA, Health/Health Care Administration/Management

• Point Loma Nazarene University

  Bachelor of Science - BS, Registered Nursing/Registered Nurse

  1995 — 2000

• UCLA

  Master's degree, Nursing Science

  2006 — 2008