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Clinical Systems Specialist
Salt Lake City, UT
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. (http://www.kalvista.com) is focused on the discovery, development, and commercialization of novel, oral therapies for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, UK; Zug, Switzerland; and Salt Lake City, UT.
The company has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization.
KalVista seeks a Clinical Sytems Specialist, which is critical to the organization's mission as it prepares to commercialize sebetralstat, a novel, oral plasma kallikrein inhibitor. KalVista recently reported positive results from the KONFIDENT Phase 3 study which demonstrated that sebetralstat met all primary and secondary endpoints for the on-demand treatment of HAE attacks and the safety profile was comparable to placebo. The Company plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) in the first half of 2024 and expects to file for approval in Europe and Japan later in 2024.
Reporting to the Director, Data Management & Systems, the Clinical Systems Specialist is responsible for ensuring KalVista Pharmaceutical’s clinical systems are compliant with regulatory & industry expectations and providing ongoing support for the day-to-day operations of study teams.
Responsibilities:
Requirements:
Full Time
$84k-107k (estimate)
05/04/2024
05/17/2024
kalvista.com
KENDALL SQUARE, MA
50 - 100
2004
T ANDREW CROCKETT
$10M - $50M
Pharmaceutical