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@incardatherapeutics.com
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Chris Dufton, Phd is listed as Clinical Development and Operations Expert with +25 years of Clinical Research Experience at Edgewise Therapeutics, based in Nederland, Colorado, United States. AeroLeads shows a work email signal at incardatherapeutics.com, phone signal with area code 650, and a matched LinkedIn profile for Chris Dufton, Phd.
Chris Dufton, Phd previously worked as Vice President, Clinical Development Operations at Edgewise Therapeutics and Senior Vice President, Clinical Development at Incarda Therapeutics. Chris Dufton, Phd holds Doctor Of Philosophy - Phd, Molecular, Cellular, And Developmental Biology from University Of Colorado Boulder.
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Pharmaceutical development leader with more than 25 years of clinical research experience and a proven track record generating positive results. Substantial expertise in Phase 1-4 clinical development, including pharmacokinetic, dose-identification, pivotal efficacy/safety, and label expansion studies. Strategic and hands-on regulatory experience in the US and EU with complex proposals such as Orphan Drug, Fast Track, SPA and CTD/NDA submissions. Directed post-approval clinical activities related to commercial launch, Phase 4 development, and publication plans.Specialties: Phase 1-4 clinical development, regulatory strategy, medical communications/publications
Listed skills include Strategy, Clinical Development, Clinical Trials, Oncology, and 18 others.
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Boulder, CO, US
Head of development operations for cardiology program evaluating cardiac myosin modulators for the treatment of patients with hypertrophic cardiomyopathy and and other serious diseases of cardiac diastolic dysfunction. Initiating first-in-human and first-in-patient studies for EDG-7500.
Newark, California, US
Clinical development for a privately-held, clinical-stage biopharmaceutical company pioneering novel approaches for the treatment of cardiovascular conditions by the inhalation route.
Clinical research and development lead for a small biopharma company focused on precision medicine based cardiovascular therapies. Designed and analyzed an adaptive, seamless Phase 2b/3, comparative efficacy trial investigating bucindolol hydrochloride for the prevention of atrial fibrillation in a genotype-defined heart failure population. Recruited and.
Independent consultant providing clinical, regulatory, and business development strategies to the pharmaceutical and biotech industries. Past projects include: clinical, regulatory, and business development for a start-up company focused on targeted radiopharmaceutical drug-device therapies for locally-advanced cancers; protocol design, regulatory and.
Foster City, CA, US
Project leader responsible for a cross-functional team that provided strategic and tactical recommendations to senior management for the post-launch development of ambrisentan. Developed comprehensive Phase 4 development plan to leverage product strengths and expand commercial adoption, including design of a major event-driven outcomes study in PAH. Guided.
Directed a team of internal clinical scientists, external vendors, and contract medical writers who were responsible for creating 11 clinical study reports and five CTD clinical summary/overview sections in less than one year. Assigned projects, created timelines, led scientific reviews, and wrote or edited all clinical sections of the NDA. Successfully.
Designed, authored, and executed multiple clinical study protocols and amendments (Phase 1-3). Participated in teleconference and face-to-face meetings with the FDA and functioned as the primary company liaison with key opinion leaders and steering committee members. Developed statistical analysis and data management plans. Wrote/edited numerous regulatory.
Aurora, CO, US
Performed clinical pharmacology research in patients receiving high-dose chemotherapy in conjunction with autologous bone marrow transplantation or hematopoietic stem cell support. Supported Phase 1-3 clinical oncology trials, conducted pre-clinical animal studies, and performed pharmacokinetic modeling for both clinical and animal studies. Conducted.
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Chris Dufton, Phd works for Edgewise Therapeutics.
Chris Dufton, Phd is listed as Clinical Development and Operations Expert with +25 years of Clinical Research Experience at Edgewise Therapeutics.
AeroLeads has found 1 work email signal at @incardatherapeutics.com for Chris Dufton, Phd at Edgewise Therapeutics.
AeroLeads has found 1 phone signal(s) with area code 650 for Chris Dufton, Phd at Edgewise Therapeutics.
Chris Dufton, Phd is based in Nederland, Colorado, United States while working with Edgewise Therapeutics.
Chris Dufton, Phd has worked for Edgewise Therapeutics, Incarda Therapeutics, Arca Biopharma, Rubicon Sciences Llc, and Gilead Sciences Inc.
You can use AeroLeads to view verified contact signals for Chris Dufton, Phd at Edgewise Therapeutics, including work email, phone, and LinkedIn data when available.
Chris Dufton, Phd holds Doctor Of Philosophy - Phd, Molecular, Cellular, And Developmental Biology from University Of Colorado Boulder.
Chris Dufton, Phd is listed with skills including Strategy, Clinical Development, Clinical Trials, Oncology, Medical Writing, Drug Development, Regulatory Submissions, and Regulatory Affairs.
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