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.
The Director, Medical Affairs Research is responsible for supporting strategic and operational activities of Medical Affairs Department and other functions at Intercept (eg, R&D, safety) through real world evidence (RWE) generation. An integral part of Medical Affairs Research is the conceptualization and execution of scientifically credible research on Intercept products and their disease states / therapeutic areas. The development of a medical research plan involves internal and external stakeholders to identify the most important research questions that will beneficially impact patient care. Successfully answering these questions will require the design of research that is fit for purpose (investigator initiated research plan; pharmacoepidemiology research, registries, Health Economics and Outcomes Research (HEOR), etc) with partnerships from other parts of medical affairs, Scientific communications, clinical development and commercial functions.
* Collaborate with Medical Affairs colleagues to help to assist in the development and execution of strategy and tactics with appropriate prioritization and use of resources.
* Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies intended to provide insight into background epidemiology and/or quantify benefits and/or risks potentially associated with Intercept products
* Project management oversight - ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, project costing and where appropriate contracting with partner organizations
* Provide epidemiological, HEOR, patient-reported outcomes, or/and RWE consulting and support to brand teams, program teams, and safety, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature as agreed by the team
* Assist with development of epidemiology sections for relevant regulatory documents and/or other regulatory filings for products throughout life cycle
* Collaborate with scientific communication and medical directors in development and communication of key literature analyses to internal stakeholders; provide strategic support of publication planning and participate on publication team to provide medical and scientific oversight to publication and scientific presentations
* Serve as scientific knowledge support through expertise in company products and related therapeutic area(s) to internal stakeholders
* Stay up-to-date on new data and developments in the field, key publications of interest, research methodologies and regulatory standards.
* Represents Intercept at medical meetings, conferences, advisory boards, outreach meetings at key institutions and in interactions with thought leaders, as relevant
Experience and Skills
* MD, PhD, MPH, PharmD, RN or PA with at least 5 years' experience years' experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
* Experience in design, conduct and oversight of real world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication.
* Solid understanding of the cross functional drug development processes (Clinical operations, Data Management, Biostats, and Regulatory)
* Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
* Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
* Ability to explain strengths and limitations of clinical practice datasets - such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources - in context of designing pharmacoepidemiology study designs
* Ability to work successfully in a matrix and quick paced environment
* Ability to multitask priorities to align with program objectives.
* Launch team experience and hepatology/GI experience strongly preferred
REQUIRED KNOWLEDGE AND ABILITIES:
* Strong knowledge of pharmacoepidemiologic methods
* Strong understanding of drug development and commercialization concepts
* Strong verbal and written communication skills are essential
* Strong inter-personal skills and problem-solving capabilities
* Ability to work independently in a proactive manner
* Able to create, track and plan timelines and budgets
* Proficient in Microsoft Project, Excel, PowerPoint & Word