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 Director, Clinical Research.
The Director, Clinical Research will be a highly qualified and motivated individual who will serve on cross-functional teams to further the development of compounds in early-stage development. This position is specifically responsible for developing clinical strategy in alignment with the business and R&D strategies to sustain the pipeline. The Director of Clinical Research will lead and drive the design and execution of Phase 1 / Phase 2 / Phase 3 clinical trials globally, as assigned, including driving the reports of outcomes and results, and collaborating for the dissemination of the resulting data to internal and external stakeholders. at internal and external forums; key point of contact for scientifically-based initiatives.
The successful candidate must be able to perform each of the following satisfactorily:
- Translate concepts/strategies into specific objectives and activities to effectively achieve goals
- Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.
- Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents.
- Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.
- Provide scientific expertise and support to externally facing groups, including the field medical team, medical information, research and development strategy team, and the commercial organization.
- Contribute to departmental resource planning, budgeting, and timeline setting to meet company needs
- Provide oversight and coaching to more junior clinical research scientists
- 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
Clinical Development Activities
- Collaborate with colleagues on a matrix team to ensure the optimal planning, implementation and interpretation of clinical studies to advance the pipeline
- Provide scientific/medical oversight to the development and maintenance of clinical development plans for early stage compounds
- Provide scientific direction and oversight to the planning, conduct, review, and interpretation of clinical trials
- Contribute to the strategic planning, authoring, and review of regulatory documents; Support regulatory interactions
- Provide scientific/medical oversight to scientific data disclosures including publications and commercial support documents
- Provide scientific expertise and support to externally facing groups, including the field medical team, medical information, and the commercial organization.
- Build productive relationships with investigators, key opinion leaders, and key stakeholders in the medical/scientific community
- Lead development of specific scientific topics of interest such as those for discussion at advisory boards (Clinical advisory boards, Medical advisory boards, etc).
- Collaborate with Business Development in the identification, early evaluation, and due diligence of opportunities for investment or acquisition.
- Other duties as assigned.
Experience and Skills
- Pharm D., M.D. or Ph.D. in a related field with 5 years or more direct biotechnology/ pharmaceutical industry experience in Clinical Research preferred; or Bachelor's/Master's degree in a scientific discipline with equivalent additional direct Clinical Research experience.
- Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal or related field, preferred.
- Prior industry experience in contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents. Prior industry experience in interactions and support of Medical Affairs and Commercial groups and activities.
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
- General familiarity with biostatistics; expert in a wide-range of clinical trial designs, navigating scientific literature, interpretation of data, display of data.
- 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).
- Familiarity with the application of software platforms such as J-review, Spotfire, TriNetX, etc. to Clinical Research.
- Ability to travel, in some cases, internationally. (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: 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