The Director, Global Medical Affairs Research is responsible for supporting strategic and operational activities of Medical Affairs Department through real world evidence generation. As an integral part of Global Medical Affairs Research is the conceptualization and execution of scientifically credible research on Intercept products and the areas of medicine they are indicated. The development of a Medical Research Agenda involves internal and external stakeholders to identify the most important research questions that will influence patient care. Successfully answering those questions will require the design of research that is ‘fit for purpose’ with partnerships from Medical Science Liaisons, Scientific Communications, Medical Safety and Pharmacovigilance Clinical Development, and the Commercial Team.
ESSENTIAL FUNCTIONS:
Collaborate with Medical Affairs colleagues to help to guide and assist in the development and execution of therapeutic area strategy and tactics with appropriate 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 epidemiological studies. Ensuring effective study protocols and plans, project costing and where appropriate contracting with partner organizations
Provide epidemiological consulting and support to product teams, 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 commercial partners on developing a Medical Communications plan that is supportive of strategic medical objectives
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, and key publications of interest
Represents Intercept at medical meetings, conferences, advisory boards, outreach meetings at key institutions and in interactions with thought leaders, as relevant
QUALIFICATIONS:
MD or PhD with at least 5 years’ experience or MPH with at least 7 years’ experience in Epidemiology, a Quantitative Public Health discipline, or related discipline in a pharmaceutical industry
Experience in design, conduct and oversight of epidemiology studies and in particular, post-approval safety studies ranging from protocol writing to project management oversight
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
Familiarity with protocol design and implementation; must have written protocols themselves (not just evaluated those written by others)
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 heapatology/GI 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
Internal Number: 85486-303371
About Intercept Pharmacueticals
We are looking for enthusiastic and hard-working individuals who embody our values.
We’re a growing biopharmaceutical company working to make a difference in the lives of people with progressive non-viral liver diseases. We’re expanding in anticipation of a first-in-class product launch for nonalcoholic steatohepatitis (NASH), and we’re looking to grow our dynamic and talented team with people ready to embrace the opportunity ahead.
Individuals who join the Intercept team at this pivotal point in our evolution will have the opportunity to be part of the company’s new legacy. If you are solutions-focused, strive for excellence and want to make an incredible impact on the lives of people living with non-viral liver diseases, then we want to talk to you.
For more information, contact us at [email protected]
