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 five 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 2022.
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 Principal Scientist, Preclinical/Toxicology.
The Principal Scientist, Preclinical/Toxicology will take on a diverse set of responsibilities relating to the discovery and early development of compounds in chronic, non-viral liver disease. This includes leading the design, management, and interpretation of non-clinical primary/secondary pharmacology, in vitro drug metabolism and toxicology studies conducted at Contract Research Organizations (CROs).The scientist will also support the management of academic external collaborative research including some aspects of investigator-initiated research (IIR) and some non-clinical exploratory sub-studies or ancillary studies from Intercept's clinical trials.
This scientific position not only requires insightful intellectual and communication capabilities, but also strong operational and vendor management skills to oversee assay development, in vitro and in vivo pharmacology, early phase toxicology studies, signaling pathway analysis, transcriptional regulation (including interpretation of RNAseq data), pharmacogenomics, and traditional drug development. The Principal Scientist, Preclinical/Toxicology primary/secondary will interact with multidisciplinary groups across the company including clinical pharmacology, biostatistics, clinical operations, medical affairs, pharmacovigilance, product development, legal and finance and play a pivotal role in bringing new drugs to the clinic.
The successful candidate must be able to perform each of the following satisfactorily:
- Drive and manage outsourcing and collaborations with CROs and/or academic labs for the conduct, timely execution, and reporting of in vitro and in vivo (animal) studies related to downstream targets of Intercept's drug candidates. Manage and work closely with the scientific staff to ensure alignment between Intercept and the external partners in conducting and reporting studies.
- Engage with key scientific leaders in Intercept's disease areas of interest to identify the most appropriate cell based and animal models for proof-of-concept studies for pipeline assets.
- Lead the study design, execution, analysis/interpretation and reporting of the nonclinical pharmacology, toxicology and drug metabolism pharmacokinetic (DMPK) work, supporting translational aspects of preclinical programs to clinical study designs.
- Serve as preclinical/non-clinical/toxicology subject matter expert when interacting with cross-functional matrix teams such as clinical, regulatory and safety, contributing to multiple programs from strategic and scientific planning through execution.
- Author/edit/review non-clinical pharmacology/toxicology sections of regulatory documents, including annual reports, investigators' brochures, briefing books, safety updates, IND/NDA submission documents, and responses to regulatory authority questions as needed. Provide quality control support as needed including non-clinical documents and slide decks.
- Manage and provide scientific insight for select specialty collaborations focusing on exploratory or ancillary studies from Intercept's clinical studies. Examples may include microbiome, metabolomics, pharmacogenomics, biomarkers, etc.
- Support the management of logistical activities for non-clinical and clinical IIR and Collaborative/External Research efforts, including but not limited to study review, study contracting, initiation, compound labeling and supply, study tracking, document maintenance and addressing investigator inquiries.
- Interpret scientific and medical literature for use in clinical/regulatory documents to be used in development team decisions. Prepare non-clinical data, clinical data and clinical program presentations. Support internal and external genetic and bioinformatics analyses especially in terms of data visualization.
- Scientific support of data disclosures including generation and review of manuscripts, abstracts, and conference posters.
- Represent the company at scientific and industry meetings, as needed
- 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
- Doctoral (PhD or MD/PhD) level degree in pharmacology, metabolism, genetics and molecular biology, translational biology or other relevant life science discipline.
- Minimum 7 years of biotech/pharmaceutical industry experience in design, conduct and authorship of original scientific publications, and contribution to the preparation of non-clinical protocols, study reports, IND, IB, NDA/CTD document.
- Direct CRO management and/or academic lab management experience strongly preferred.
- Direct experience in GCP, ICH guidelines and FDA regulations required. Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements highly preferred.
- General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
REQUIRED KNOWLEDGE AND ABILITIES:
- State of the art knowledge of hepatocellular signaling processes, including nuclear- and G-protein coupled receptor activation, gene transcription and bio-informatic approaches to analysis of drug targets
- Ability to integrate assay development, biological systems, physiology, pharmacology, toxicology, and DMPK with drug development programs.
- Strong interpersonal skills especially as it relates to collaboration and vendor management; proactive approach; collaborative and flexible in personal interactions at all levels of the company.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously and able to deal with ambiguity.
- Results driven and able to achieve creative and sound outcomes
- Demonstrated problem-solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Highly proficient in standard computer software (Word, Excel, and Power Point); Proficiency in GraphPad desirable.
- Ability to travel (average travel expectations
- 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: Come Together, Be Yourself, Own the Solution, Embrace the Challenge, Keep Exploring.
- Ability to have fun and thrive in a growing, diverse, and inclusive work environment