Job Title: Medical Science Liaison (MSL) m/w
Location: Field-based, Germany (Hamburg/Hanover/Berlin)
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. OCA, marketed under the brand name \"Ocaliva®,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (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. 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 submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. 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 anticipated launch of OCA's second indication.At Intercept, our mission is to build a healthier tomorrow forpatients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid(OCA), is a 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 certain patients with primarybiliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva®was the first product to be approved for PBC in over twenty years and our teamis proud to have been pioneers in providing the first second-line treatmentoption to patients with such critical need. The Ocaliva® launch in 2016 also marked Intercept'ssuccessful transition from a development-stage company to a fully integratedcommercial organization with continued growth.
In February 2019, Intercept reported positive topline results from thePhase 3 REGENERATE study of OCA in patients with liver fibrosis due tononalcoholic steatohepatitis (NASH), which impacts the lives of millions ofpeople in the U.S. alone. Currently, there are no available treatments forNASH, and Intercept is among the leading companies focused on the disease.
As Intercept continues to build its position as the leader inprogressive non-viral liver disease and pursues its goal of bringing the firstapproved therapy to patients with NASH, we are seeking an experienced Medical Science Liaison to join our German Medical Affairs team.
The role of the MSL is full time, non-promotional and field based. It provides a key Intercept Medical Affairs interface with Healthcare Professionals (HCPs), Pharmacists and Scientists to enable scientific exchange, ultimately to ensure the safe and effective use of Intercept Medicines. Working internally, the MSL role can also help to shape strategy so that Intercept activities and deliverables align with the non-promotional needs of HCPs and the healthcare system.
MSL communication relating to licensed, off label or pipeline product use is required to be reactive unless proactive communication is necessary to protect patient safety. The MSL may proactively seek and elicit information regarding clinical practice, current scientific thinking or other aspects of the therapeutic area for educational purposes and in order to inform company strategy and activities as set out above.
The successful candidate must be able to perform each of the following satisfactorily:
- Providing non-promotional support to enquiries received by the Medical Information department, by colleagues in commercial functions or directly received by them. Whether enquiries relate to within or off label use of Intercept medicines, the highest quality of available information must be made available to optimise outcomes
- Providing fair, balanced and factual information upon request. This may be take the form of a group presentation (at symposia, scientific meetings or departmental meetings), face to face discussion or written communication
- Identify, gain access to, and develop professional relationships with thought leaders, active and potential study investigators and professional organisations within assigned geography
- The delivery of scientific and medical training internally and externally with clinicians, pharmacists, nurses and associated scientific personnel.
- Collaboration with Clinical Operations to provide support to investigator and CRO personnel in the conduct of Intercept studies and provision of reactive support to investigator initiated research
- Reporting of adverse event information and proactive follow up of safety reports as required by the pharmacovigilance department
- Collaboration with external experts and thought leaders on scientific and clinical papers / posters for publication in medical journals and at congresses
- Assisting with evidence generation and stakeholder management needs of Health Technology Assessment and patient pathway optimisation activities
- Gathering and reporting of scientific and medical insights resulting from their external interactions
- Attend and support scientific/professional meetings/conferences consistent with areas of therapeutic responsibility
- Assisting the Medical Affairs team as required to execute the Medical Affairs plan, including the conduct of Advisory Board or other bona fide elicitation activities (eg. External steering group meetings, 1:1 consultancy)
- Working cross functionally within country brand teams, providing sound medical support and input into plans, informed by in depth therapeutic area, external stakeholder and local health system knowledge
- Continued personal and professional development through identification and proposal of suitable training, Continuous Professional Development and other therapeutic area educational activities to be approved by their line manager
- At all times working strictly within the remit of local codes of practice, laws and regulations
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
Experience and Skills
- Medical degree, PhD, PharmD or relevant higher science degree
- Firsthand knowledge and experience of hepatology as a healthcare professional or relevant experience in a previous pharmaceutical role
- Other relevant experience in hepatology, gastroenterology and/or endocrinology
REQUIRED KNOWLEDGE AND ABILITIES:
- Strong verbal, written communication, presentation and interpersonal skills
- Bi-lingual professional use and communication of English and German, both written and verbal
- The ability to build and develop suitable external HCP and scientific networks and work collaboratively with diverse internal stakeholders
- A strong scientific background and excellent organisational skills
- The MSL must be prepared to spend the major proportion of their time in the field, entailing frequent travel within Europe, and occasionally further afield
- The ability to work flexibly and prioritise competing demands with minimal supervision
- Excellent working knowledge of the codes, laws and regulations governing the Pharmaceutical Industry and the conduct of personnel
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Understanding the legal and compliance environment
- Ability to have fun!
This is a unique opportunity to join Intercept at an exciting time as we prepare for our next potential product launch, and to play a key role in the German Medical Affairs team.
To apply, please send an up-to-date cv and cover letter in English before Friday 5th June 2020