Current Postings

Director, Global Medical Affairs Research

Description


POSITION SUMMARY:

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

Location: New York,
Job Type: Full-time

Contact


Contact: Jason Noe
Phone: 646-931-1217
Email: jason.noe@interceptpharma.com
Website: https://interceptpharma.submit4jobs.com/#/jobDescription/303371/Director,%20Global%20Medical%20Affairs%20Research

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