Clinical operations leadership and elite site relationship management for the biotechnology sector. Bridging the gap between protocol design and on-the-ground reality to drive enrollment, protect data integrity, and build site engagement.
Applying Clinical Psychology to Clinical Operations.
"A scientifically brilliant protocol is ultimately worthless if the clinical site lacks the bandwidth or motivation to execute it."
The modern clinical trial landscape is paralyzed by site fatigue, complex digital endpoints, and patient retention bottlenecks. Technical expertise is required, but it is no longer sufficient. With an academic foundation in clinical counseling (M.Ed.) paired with 27 years of sponsor and CRO experience, I bring a unique psychological edge to Clinical Site Relationships.
I do not simply oversee the quality of sites; I actively listen, diagnose friction points, and apply seasoned communication skills—including site staff motivation and conflict de-escalation—to build profound trust with Principal Investigators, study coordinators and the entire research team. By transforming ineffective sponsor and CRO site dynamics into collaborative partnerships, I partner with the sites to unblock stalled enrollment.
Site engagement and enrollment in rare disease studies. Strengthening vendor relationships to improve study execution. Collaborative and informed support of sponsor study teams.
Establishing partnerships with Key Opinion Leaders (KOLs), Principal Investigators, and all members of the site study team. Acting as the sponsor's elite liaison to remove institutional roadblocks, drive patient enrollment in highly competitive rare disease indications, and ensure sites prioritize your trial amidst competing priorities.
High-level strategic oversight for complex Phase II and Phase III global programs. Extensive experience guiding pivotal trials toward NDA submission, managing global CROs, and ensuring strict ICH-GCP inspection readiness. Specialized expertise in the operational demands of rare disease.
Deploying into stalled or underperforming trials to diagnose root causes of delay at the site level from assessment of regional feasibility assessments to study start up and to site close out. Deep historical expertise in subjective endpoint standardization and rater reliability.
27 years of clinical excellence—from ground-level site coordination to managing and overseeing site relationship teams across the globe.
Pharvaris 2022 – 2026
Focus: Hereditary Angioedema (HAE) · Rare Disease
Provided global clinical leadership for pivotal Phase 2 and Phase 3 trials, including the RAPIDe-3 study, which met its primary endpoint and all 11 secondary efficacy endpoints. Directed multinational site relationship project teams, oversaw CRO site performance, and drove operational milestones.
Janssen (Johnson & Johnson) 2020 – 2021
Focus: Portfolio-Wide Clinical Strategy · IDN Contracting
Managed strategic partnerships with tier-one academic research institutions. Bridged site clinical operations hurdles by resolving study obstacles related to budget, vendors and quality.
Momenta Pharmaceuticals 2019 – 2020
Focus: Autoimmune Disorders · Rare Disease
Pioneered proactive, relationship-driven site engagement strategies to unblock enrollment bottlenecks and foster deep loyalty among Principal Investigators and research staff for complex targeted biologics.
EMD Serono · Endo · MedAvante-ProPhase 2013 – 2019
Focus: Neuroscience · Immunology · Oncology
Managed rigorous global clinical operations on the sponsor side, standardized subjective endpoints (eCOA) to mitigate placebo response in complex CNS trials, and oversaw global investigator-sponsored studies (ISS) for leading biopharma sponsors.
Registrat MAPI · United BioSource · Suburban Research 1999 – 2012
Focus: Late-Phase (Phase IV) · Real-World Evidence · ePRO
Built a foundational, bottom-up understanding of site administrative burden, ePRO implementation, and multinational observational trial logistics—starting directly at the site coordinator and clinical rater level.
Master of Education in Counseling
Widener University
Bachelor of Arts
Roanoke College
A rare duality: the institutional rigor of Janssen-scale trial execution paired with the high-pressure agility of venture-backed biotech execution at Pharvaris and Momenta. Bringing Clinical Trial Site and Big Pharma strategic discipline to the trials that can least afford friction.
Explore the methodologyI partner with forward-thinking biotechnology and pharmaceutical leadership teams who understand that site engagement is a strategic imperative, not an administrative afterthought. Whether you need fractional leadership to guide a pivotal Phase 3 program to regulatory submission, or targeted site liaison interventions to rescue a stalling rare-disease trial—let's talk.