Sarah Gallagher Email and Phone Number
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As a Global Clinical Affairs Executive, I lead the end-to-end management of clinical studies in the medical device industry across the United States, Canada, and Europe. From design to evidence dissemination, I drive the seamless execution of clinical trials, taking a patient-centered approach and delivering innovative healthcare advancements. Overseeing initiatives to treat complex cardiovascular diseases, my specialty is cardiac rhythm management, interventional cardiology, structural heart, neuromodulation, and interventional pain. Directing the strategic planning, execution, and management of clinical research efforts, I work cross-functionally to design and implement clinical trial protocols, ensuring compliance with regulatory guidelines and industry best practices.I have pioneered one of the largest double-blind sham control trials in interventional cardiology and guided the release of data for the largest clinical trial to date on radio-frequency ablation for metastatic bone tumors.As a strategic leader, I cultivate strong, collaborative partnerships with key opinion leaders (KOLs) and contract research organizations (CROs) to successfully secure IDE approvals and CMS code for pivotal blinded IDE studies. My teams are agile and resilient, adapting to dynamic challenges and delivering exceptional results in complex and highly regulated environments to improve lives through medical device innovations.
Melodi Health
View- Website:
- melodihealth.com
- Employees:
- 7
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Melodi HealthMinneapolis, Mn, Us
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Vice President, Clinical And Medical AffairsMelodi Health Feb 2024 - PresentMinneapolis, Minnesota, Us
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Vice President (Vp) Clinical AffairsNeovasc Inc. 2021 - 2023Richmond, B.C., CaDrove clinical affairs as strategic leader, providing direction to facilitate business efforts. Managed 14 staff and a multi million dollar budget to develop and execute clinical trials ensuring compliance with clinical trial guidelines and requirements. -
Senior Director Clinical AffairsStereotaxis 2021 - 2021St Louis, Missouri, UsNegotiated study design with Food and Drug Administration (FDA) throughout pre-submission process in preparation for IDE submission. Determined clinical evidence strategy for new product introductions. Executed three global studies. Created SOPs to ensure compliance with FDA regulations and EU regulations. Oversaw performance of selected CROs. -
Director Clinical ResearchMedtronic 2019 - 2020Minneapolis, Mn, UsDirected clinical research for interventional pain business treating vertebral compression fractures with balloon kyphoplasty and ablation for metastatic bone cancer. Facilitated evidence dissemination and publication planning for trial completing enrollment and ensured compliance with changes in medical device regulations. Served as member of VP / GM staff accountable for setting strategic priorities and executing clinical programs. -
Senior Manager Clinical ResearchMedtronic 2015 - 2019Minneapolis, Mn, UsServed as leader of clinical quality, clinical evaluation report writing, and controlled release teams to advance business across all therapy areas for implantable therapies. Set team priorities and ensured alignment with cross-functional partners. Ensured projects were completed on schedule and budget and met regulatory requirements.
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Manager Clinical ProgramsSt. Jude Medical 2012 - 2015St. Paul, Minnesota, UsManaged Left Atrial Appendage Closure portfolio of clinical studies, including IDE and global post-market study throughout Europe. Developed clinical study strategies, including enrollment forecasts, budgets and timelines, and clinical protocols to support new product approval. Worked globally and cross-functionally to ensure successful execution of clinical trials -
Manager Clinical ResearchMedtronic 1999 - 2012Minneapolis, Mn, UsLed three large new indication trials with a staff of eight and two post-market studies focused on evidence generation. Directed cross-functional team over a year through Premarket approval (PMA) submission, panel preparations, and FDA negotiations that resulted in an expanded indication for Medtronic family of devices, benefiting 220,000 patients and providing incremental revenue for the company. Trained KOL on FDA approval process, which resulted in study’s incorporation into PMA and presentation before FDA advisory panel. Promoted five times over tenure.
Sarah Gallagher Skills
Sarah Gallagher Education Details
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University Of St. ThomasTechnology Management -
University Of Minnesota DuluthExercise Science
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University Of Minnesota DuluthPsychology
Frequently Asked Questions about Sarah Gallagher
What company does Sarah Gallagher work for?
Sarah Gallagher works for Melodi Health
What is Sarah Gallagher's role at the current company?
Sarah Gallagher's current role is Global Clinical Affairs Executive | Clinical Trials | Regulatory Compliance | Innovation | Patient-Focused | Stakeholder Management | Cardiac Rhythm Management | Structural Heart | Neuromodulation | Medical Devices.
What is Sarah Gallagher's email address?
Sarah Gallagher's email address is sa****@****nic.com
What is Sarah Gallagher's direct phone number?
Sarah Gallagher's direct phone number is +165175*****
What schools did Sarah Gallagher attend?
Sarah Gallagher attended University Of St. Thomas, University Of Minnesota Duluth, University Of Minnesota Duluth.
What skills is Sarah Gallagher known for?
Sarah Gallagher has skills like Clinical Trials, Medical Devices, Fda, Clinical Development, Cardiology, Ctms, Interventional Cardiology, Cross Functional Team Leadership, Electrophysiology.
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