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 marketed under the brand name "Ocaliva®" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a di¬fference in the lives of patients, Intercept is a great place to be.
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