Intercept Pharmaceuticals Inc.
Senior Medical Director, Clinical Research (Finance)
COMPANY SUMMARY:
At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name \"Ocaliva®,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). REGENERATE is the first and largest Phase 3 study in NASH - a chronic disease that threatens the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
Based on the positive results from REGENERATE, Intercept submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Clinical Development will play a pivotal role in preparing the company for the successful anticipated launch of OCA's second indication.
POSITION SUMMARY:
Provide broad scientific and/or medical input to activities that span across the scope of clinical research, including contribute to/lead the strategic planning and execution of clinical research plans, provide medical support of regulatory submissions, contribute and provide medical input to commercial initiatives and medical affairs.
CORE ACCOUNTABILITIES:
The successful candidate must be able to perform each of the following satisfactorily.
Major responsibilities include:
Experience and Skills
QUALIFICATIONS: