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 difference 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, we are seeking a Director, Pharmacometrics. This position plays a key role in directing the clinical pharmacology/pharmacometrics group's effort to inform drug development decision-making using data analysis, modeling, and simulations. The Director, Pharmacometrics integrates preclinical, clinical, and DMPK information to support mechanism of action (MOA), drug-drug interactions (DDI), study design, exposure-response relationships, dosing rationale, and go/no-go decisions on preclinical and clinical candidates. Responsible with guidance from the Vice President, Clinical Research, for all reporting, documentation, datasets, and modeling.
The successful candidate must be able to perform each of the following satisfactorily:
- Organize, perform and execute clinical pharmacology analyses including pharmacokinetic modeling and simulations, exposure-response (ER) assessment, exposure-safety assessments, and pharmacokinetic/ pharmacodynamic (PK/PD) analyses.
- Execute and support modeling and other analyses for activities from research through publication of various programs.
- This person needs to not only understand the fundamentals of pharmacometrics but also organizing statistical programming to assist in the analyses.
- Contribute to protocol sections, analysis plans, study reports as well as regulatory documents (INDs, CTAs, NDAs, MAAs and Investigator's Brochure) as needed.
- Support preparation of responses to agency questions and attend meetings with regulatory agencies as necessary.
- Use innovative modeling techniques to inform clinical trial design and outcome analyses.
- Lead and oversee any outsourced PK/PD activities.
- Management of personnel within the Pharmacometrics line function
- 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
- Ph.D. in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics or a related discipline
with at least 6years of direct Clinical Pharmacology experience or Masters in Pharmacometrics with at least 10years of direct Clinical Pharmacology experience.
- Thorough understanding of and hands-on experiences with pharmacokinetic modeling including compartmental, population PK, physiologic based PK, and hybrid models
- Extensive experience modelling in appropriate software (NONMEM, Phoenix NLME, SAS)
- Experience managing direct reports is optional but preferred
REQUIRED KNOWLEDGE AND ABILITIES:
- Proven ability to work independently, proactively, and effectively
- Demonstrated ability to multi-task and prioritize assignments to ensure work is completed efficiently.
- Experience working in a matrix environment and with different leadership styles
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Ability to have fun and thrive in a growing, diverse and inclusive work environment