Intercept Pharmaceuticals Inc.
Senior Manager, Safety Evaluation & Risk Management (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 Medical Safety and Pharmacovigilance will play a pivotal role in preparing the company for the successful anticipated launch of OCA's second indication.
POSITION SUMMARY:
The Sr. Manager, Safety Evaluation & Risk Management (SERM) supports the medical and scientific functions for safety evaluations for assigned products. Such tasks include oversight and conduct of standardized safety surveillance, oversight and preparation and coordination of reviews of individual case safety reports, and aggregate safety data.
CORE ACCOUNTABILITIES:
The successful candidate must be able to perform each of the following satisfactorily.
Provide scientific oversight to safety activities for the Intercept Safety Physicians, as appropriate, based on data from clinical trials and post-marketing experiences. Recommend strategy and author safety analyses with alignment of Safety Physicians. Lead strategy and oversee clinical trial and post-marketing safety monitoring activities, lead the preparation of aggregate reports, Risk Management Plans, and assessments of benefit-risk. Conduct the evaluation of safety signals according to standard operating procedures (SOPs), work instructions (WIs), and guidelines. Ensure safety issues are documented and communicated to the appropriate stakeholders in a timely fashion. Author and lead the preparation of aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSUR/PBRER), US Periodic Adverse Drug Experience Report (PADER), etc. Support preparation of drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, and Product Labeling. Participate in Pharmacovigilance Review Committee meetings.
The Sr. Manager, SERM has an advanced academic degree biological or natural science or health-care discipline (e.g. PharmD, MPH, etc.). Previous experience within the pharmaceutical industry and at least 6 years of post-marketing and clinical safety data analysis preferred but not required. Familiarity with industry principles of drug safety, drug development, pharmacology, biostatistics, and pharmacoepidemiology.
Responsibilities and skills include:
Experience and Skills
QUALIFICATIONS