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Work Background
CORVIVO CARDIOVASCULARVP of Clinical Research
Feb. 2025Driving the strategy and execution of pivotal clinical programs, ensuring our groundbreaking regenerative heart technologies not only meet the highest scientific, regulatory, and commercial standards but also redefine the future of structural heart therapy. With a first-in-class regenerative tricuspid valve and a mission to disrupt the structural heart market, I lead our studies, refine protocols, and bring transformative solutions to patients. From ensuring regulatory compliance to overseeing trial execution and data integrity, my role is focused on accelerating Corvivo’s path to becoming the first company to achieve FDA approval for a regenerative heart valve—and pioneering a new era of cardiovascular repair and regeneration.
Self-employedLeadership Coach
Jan. 2024With a passion for leadership development and a commitment to excellence, I have become a trusted advisor and coach. My core values are Generating Enthusiasm for Change, Taking Action, and Getting Results. As a recent graduate of an International Coaching Federation (ICF)-Certified PCC Level coaching program, I am equipped with contemporary methodologies and a deep understanding of what drives personal transformation. I excel in high-stakes, high-stress scenarios, understand the challenges of analytical thinkers, and have experience working with leaders who feel marginalized. Having navigated a demanding and high-pressure career in healthcare and biotechnology, I have developed an acute insight into the intricacies of effective leadership and human dynamics. As a coach, I believe in the power of the individual to transform themself and adopt a personalized approach, focusing on each leader’s unique opportunities, desires, and whole self. I guide leaders to uncover the enthusiasm and momentum to do their best work without setting limits on their growth and success. I am committed to creating a safe, open, collaborative coaching environment where leaders feel empowered to explore, learn, and evolve.
Olympus Corporation of the AmericasVP, Global Head of Clinical Affairs
Oct. 2021 - Oct. 2022Westborough, Massachusetts, United StatesOwned all aspects of clinical study management worldwide with US, EU, and Japanese team members. Collaborated with Medical Affairs and Statistics/RWE to run clinical studies supporting clinical evidence-generation strategies across all business unit portfolios - including gastrointestinal, urological, respiratory ENT, and digital health applications. Worked cross-functionally to set various operational standards for Olympus to become a global MedTech leader.
Modern Women in STEM ProjectFounder and Editor
Sep. 2018Exeter, Rhode Island, United States and New York, New York, United StatesEditor of the collaborative memoir entitled Determined to be Extraordinary Spectacular Stories of Modern Women in STEM (Bradway Publishing, 2024). Determined to be Extraordinary was a #1 New Release in the Reference & Collections of Biographies, Scientific Reference, and Children's Inventors Books categories on Amazon. Twenty-seven inspiring women leaders in STEM from around the world were brought together to tell their original, passionate stories describing their perseverance, spirit, brilliance, and personal growth through words and photographs. Sadly, books about women in science for young girls are history books. Determined to be Extraordinary will be the first book designed to motivate young girls to pursue STEM careers by presenting real-life examples of women successful in STEM.
BDSenior Director, Clinical / Medical Affairs
Mar. 2017 - Sep. 2021Warwick, Rhode Island, United StatesInspired associates to maximize their engagement in projects and expand their talents to accelerate timelines. Managed the Global Clinical Affairs strategy and planning for products in hernia repair, breast reconstruction, and surgical hemostasis, including New Business Development and Post Market Clinical Follow Up (PMCF) studies for compliance to EU MDR.
Bard DavolDirector, Clinical Affairs
Apr. 2011 - Feb. 2017Warwick, Rhode Island, United StatesSet the Vision and the Mission for the department. Built and maintained the clinical affairs function supporting product development and business objectives including New Business Development. Maintained strong internal and external relationships/partnerships.
Johnson & JohnsonManager, Clinical Research
Nov. 2005 - Apr. 2011Raynham, Massachusetts, United StatesLed drug, device, and biologic clinical research in the US and EU that included strategic plans for reimbursement. Managed 11 FTEs and contract resources working on behalf of three J&J operating companies. Managed and forecasted departmental budget over $6 million. Created and implemented corrective and preventive actions for internal QA/QC activities.
Bayer HealthCareAssociate Director, Phase IV Studies
Jan. 2003 - Nov. 2005West Haven, Connecticut, United StatesEvaluated Phase IV (post-marketing) investigator proposals for studies in cardiovascular disease (Trasylol®, Adalat®, and Nimotop®), metabolics (Precose®), and urology (Levitra®). Quick action and flexibility were daily requirements to ensure all projects were coordinated properly. Problems that occurred were not always covered by set procedures and policies and had to be solved by sound judgment and discretion based on prior clinical and corporate business experience.
Bayer HealthCareManager, U.S. Phase IV Grants and Studies
Apr. 2001 - Jan. 2003Chairperson of the U.S. Phase IV committees that assessed study proposals and developed strategies and plans for new studies. Two committees involved another Pharmaceutical company through a co-promotional agreement. Developed relationships with key opinion leaders, investigators, contract research organizations, central laboratories, Investigational Review Boards, other central service companies and independent consultants to ensure optimal implementation of studies and Bayer’s marketing strategy.
Bayer HealthCareClinical Trial Leader
Dec. 1998 - Apr. 2001Responsible for project quality, management, communications, and timelines, including site monitoring, corrective actions, transfer of study/drug supplies, internal audits, data collection, cleaning and transfers from radiology, biological marker, and central laboratories. Developed international case report form standards for osteoporosis. Developed long-term patient retention strategies in collaboration with Marketing.
United States Surgical CorporationClinical Research Associate
Oct. 1996 - Dec. 1998Norwalk, Connecticut, United StatesRecruited, managed, and monitored investigational sites for spinal fusion cage clinical trials (pre- and post-marketing studies) and a novel balloon carpal tunnel device. Including educating staff on surgical procedures, protocol requirements, and patient safety through lectures and cadaver models. Managed 2 pivotal trials contributing to a Premarket Approval (PMA) application that led to product approval (Ray Threaded Fusion Cage). Authored investigational protocols, informed consents, patient brochures, and case report forms for Investigational Device Exemptions (IDE) for submission to FDA.
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