Intercept Pharmaceuticals Medical Director- US Medical Affairs in New York, New York
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 potent first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name “Ocaliva,” is approved in the U.S., EU and Canada for use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH – a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Medical Affairs will play a pivotal role in preparing the company for the successful launch of OCA’s second indication.
The Medical Director-US Medical Affairs will report into the Executive Medical Director US Medical Affairs and be responsible for participating in developing the Medical Affairs strategy and tactical plans and driving certain key US medical strategies and tactics for Intercepts commercialized and pipeline indications/brands, focused on the US market. The ideal candidate should be highly motivated and innovative with a clear ability to manage a matrix and have a track record of deliverables.
The Medical Director-US Medical Affairs shall have broad responsibilities for US Medical Affairs strategy and tactics and for working across Medical Affairs to ensure aligned execution by other Medical Affairs functions (HEOR, IIR, Medical Operations, Scientific Communications etc.) against the strategy. This individual shall also have the responsibility to collaborate with other matrix partners such as US commercial, Research and Development, Regulatory Affairs, Corporate Affairs, Business Development and Program Teams to ensure appropriate Medical Affairs input and direction are provided.
As a member of the US Medical Affairs team, the Medical Director-US Medical Affairs will partner with the Executive Medical Director US Medical Affairs to build and continuously improve the US Medical Affairs team.
Additionally, through the development and maintenance of relationships with the external expert community/stakeholders, the Medical Director-US Medical Affairs, will utilize his/her to skills and relationships to advance Intercept’s medical/scientific engagement in research, advisory boards, medical education and scientific communications.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Participate in the development of a cross functionally aligned set of medical strategies for the US market needs; focused on commercialized as well as late-stage development indications/assets.
Participate in building a Medical Affairs plan with specific medical tactics, in partnership with other medical functions and aligned with the medical strategies.
Provide strategic medical leadership to other medical functions as needed to ensure the delivery of aligned projects and results.
Play a key role in developing the medical strategy and plans for Medical Affairs advisory boards in the US and work with the Scientific Communications team to execute.
Key point of Medical contact with US commercial, working to provide appropriate medical input into the development of promotional pieces, support in-market launch activities, contribute strategic medical input as required to the development of brand strategies, support the business insights team with market research projects, and collaborate with the Managed Markets team to support the payer focused activities.
Responsible for the Medical part of the promotional materials legal medical regulatory review in the US.
Play a key role in development and running a medical affairs data generation and dissemination working group and work with the Scientific Communications team to develop and execute aligned strategies/tactics for maximizing our scientific communication efforts.
Work with the HEOR team to provide medical direction into real world evidence generation projects, including comparative effectiveness/value for money projects.
Primary point of Medical contact with the global Patient Advocacy team ensuring appropriate medical support is provided to all patient education efforts.
Work with the Investigator Initiated Research (IIR) team to provide appropriate medical review to concept/protocol reviews.
Serve as content expert in PBC/NASH and master the data in support of Intercept’s product(s) value proposition.
Stay up-to-date on new data and developments in the field, and key publications of interest.
Maintain strong relationships with the external thought leader and influencer communities.
Ensure interactions with thought leaders and our advocacy partners (professional and patient organizations).
Contribute to, and support execution of the lifecycle management activities for Intercept’s commercialized indications/assets.
MD/DO/PhD/PharmD with a minimum of 6 years of professional experience preferably within the bio-pharmaceutical industry and/or in Clinical Research and/or Medical Affairs.
Other biomedical degrees (NP, PA, BSPharm, MSPharm) with a minimum of 8 years of bio-pharmaceutical industry experience in Clinical Research and/or Medical Affairs.
An MPH in chronic disease epidemiology/biostatistics in addition to any of the above degrees will be a strong plus.
Prior experience in Hepatology, Gastroenterology, Immunology preferred.
Direct experience developing and executing research (interventional or observational) studies required.
Demonstrated track record of publishing in peer-reviewed scientific journals required.
Launch experience strongly preferred.
Strong understanding of drug development and commercialization process
Strong verbal and written communication skills are essential
Demonstrated ability to lead across a matrix required
Excellent organization and multi-tasking skills
Strong inter-personal skills and problem-solving capabilities
Ability to work independently in a proactive manner
Proficient in Microsoft Project, Excel, PowerPoint & Word
Keyword: Medical Director- US Medical Affairs
From: Intercept Pharmaceuticals