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 Medical Affairs will play a pivotal role in preparing the company for the successful anticipated launch of OCA’s second indication.
The role of the MSL is non-promotional and field based. It provides a key Intercept Medical Affairs interface with Healthcare Professionals (HCPs), Pharmacists and Scientists to enable scientific exchange, ultimately to ensure the safe and effective use of Intercept Medicines. Working internally, the MSL role can also help to shape strategy so that Intercept activities and deliverables align with the non-promotional needs of HCPs and the healthcare system.
MSL communication relating to licensed, off label or pipeline product use is required to be reactive unless proactive communication is necessary to protect patient safety. The MSL may proactively seek and elicit information regarding clinical practice, current scientific thinking or other aspects of the therapeutic area for educational purposes and in order to inform company strategy and activities as set out above.
The successful candidate must be able to perform each of the following satisfactorily:
REQUIRED KNOWLEDGE AND ABILITIES:
This is a unique opportunity to join Intercept at an exciting time as we prepare for our next potential product launch, and to play a key role in the German Medical Affairs team.
To apply, please send an up-to-date CV and cover letter in English