- Collaborate with cross-functional colleagues to lead the development and execution of Medical Research strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources
- Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits/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, managing budget and milestone tracking, 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 Communications team and Medical Directors in development and communication of key literature analyses to internal stakeholders; provide strategic support of publication planning and participate on Publications 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
- Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients as our top priority
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Director, Medical Research - Morristown, United States - Intercept Pharmaceuticals
Description
POSITION SUMMARY:
As Intercept continues to build its position as the leader in rare and serious liver disease, we are seeking a Director of Medical Research.
The Director, Medical Research, is responsible for supporting strategic and operational activities of the Medical Affairs department and other functions at Intercept (e.g., R&D, Medical 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 strategic evidence generation 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 (including pharmacoepidemiology research, registries, Health Economics and Outcomes Research (HEOR), oversight of investigator-initiated research plan, etc.) with partnerships from other parts of Medical Affairs, Publications and Scientific Communications, Pharmacovigilance, Clinical Development, Market Access, and Commercial functions.
CORE ACCOUNTABILITIES:
The successful candidate must be able to perform each of the following satisfactorily, with or without an accommodation:
