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), which impacts 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.
As Intercept continues to build its position as the leader in progressive non-viral liver disease and pursues its goal of bringing the first approved therapy to patients with NASH, we are seeking a highly motivated scientist to be responsible for designing clinical studies and performing, interpreting, and reporting Pharmacokinetic/Pharmacodynamic (PK/PD) results.
This individual will provide support in characterizing the clinical pharmacology profile of compounds developed by Intercept as part of the overall pipeline. In addition, the incumbent will support the pharmacometric team in constructing, validating, and implementing disease, placebo, exposure-response, and mechanistic PK/PD models to evaluate risk/benefit and facilitate drug development decisions. Based on experience, this position could serve as a Clinical Pharmacology representative on study and project teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators. This position will report to the VP of Clinical and Preclinical Pharmacology.
The successful candidate must be able to perform each of the following satisfactorily:
- Design Phase 1 studies and collaborate with the clinical team for selecting most appropriately PK sampling strategy for Phase 2 and 3 studies
- Perform, supervise, and report PK and PK/PD analyses for Intercept molecules as they progress through clinical development
- Participate to dosing selection for Phase 1 studies in collaboration with the preclinical group, and for Phase 2 and 3 clinical trials in collaboration with pharmacometric and medical teams
- Interact with pharmacologists, toxicologists, medical directors, and formulation/Regulatory Affairs personnel for the timely completion of clinical studies and regulatory filings
- Represent Clinical Pharmacology on multi-disciplinary study teams with a potential to represent the function on project teams
- Contribute to protocol sections, analysis plans, study reports as well as regulatory documents (INDs, CTAs, NDAs, MAAs and Investigator's Brochure)
- Maintain and enhance technical and drug development expertise (e.g., training courses, external meeting attendance)
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
Experience and Skills
- PharmD or PhD in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences or related discipline
- Minimum 6 years of industry experience in clinical pharmacology and/or clinical PK/PD
- Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin or similar software
- Experience with NONMEM, R and other modeling software would be preferred
REQUIRED KNOWLEDGE AND ABILITIES:
- Ability to work in a matrix environment and with different leadership styles
- Proven ability to work independently, proactively, and effectively
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Understanding the legal and compliance environment
- Ability to have fun and thrive in a growing, diverse and inclusive work environment