Job Title: Head of Medical Affairs - Italy
Location: Milan, Italy
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 marketed under the brand name \"Ocaliva ® \" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration, and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Head of Medical Affairs for our Italian affiliate.
The Head of Medical Affairs will report to the Executive Director, Medical Affairs - France, Iberia + Italy and will have direct leadership responsibilities for Medical Affairs and management of the Medical Field Advisor and MSL(s).
This person will be responsible for the development and evolution of Medical Affairs so will take the lead for the medical affairs plans for products in both late stage development phase and post-launch phase. Considerable expertise, knowledge and connections in hepatology or gastroenterology will be critical to help build the organization quickly and efficiently.
As a relatively new company, our people need to further develop credible and trusted relationships with key regional and country stakeholders, clinical, payor, community and policy and be passionate about tackling Liver led Disease. Considerable expertise, knowledge and connections in hepatology or gastroenterology will be critical to help build the organization quickly and efficiently. It is expected that the Country Head of Medical Affairs will personally spend at least 60% of time working with our external stakeholders and partners.
This role will demand an ability to work strategically and operationally in equal measures and the right person will thrive in ambiguity and possess an entrepreneurial and innovative spirit.
The successful candidate must be able to perform each of the following satisfactorily:
- Member of General Manager's Leadership Team for Italy with joint responsibility for the overall creation, implementation and governance of Italy's cross functional plans and culture.
- Responsible for ensuring medical approval for the country's activities and compliance with countries and company Business Conduct requirements.
- Responsible for liaison with the Medical Safety and Pharmacovigilance team (MSPV) and country General Managers (GMs) as necessary to ensure that applicable PV requirements are fulfilled and that the wider business need to accurately portray risk: benefit is met across all functions. This responsibility includes maintaining awareness of safety reporting KPIs, up to date product risk: benefit and any potential safety signals through regular scheduled meetings with MSPV. In order to optimize the functioning of the pharmacovigilance system, Country Head of Medical Affairs will be responsible for the communication to MSPV of any proposed affiliate activities which have the potential to generate safety or product complaint information in a timely way at the planning stage. Country Head of Medical Affairs will assist MSPV/QA as necessary in the follow up of serious or complex adverse events or product complaints with a clear implication for patient safety that are reported in their country. The Country Head of Medical Affairs will act as the key interface between MSPV and the affiliate General Managers, sharing safety information as appropriate to inform cross functional activities that they are responsible for in each affiliate.
- Establish Intercept as a highly credible partner in unmet Liver Disease to our clinical stakeholders in the region:
- External focus will be a critical part of this role.
- Collaborate with academic thought leaders to ensure that the company's products will serve the clinical needs of patients and to ensure a balanced discussion on their safety and efficacy.
- Plan the evolution of the Medical Affairs department in countries including attracting, developing and retaining talent to fulfill the mission of Intercept.
- Ensure appropriate training to maintain excellent levels of scientific and medical knowledge.
- Establish a science-based culture where we exceed our commitments and underperformance is not tolerated.
- Lead Medical Affairs activities across Italy- aligned to International and global strategy:
- Work closely with country leadership teams to develop and execute the strategic and operational medical affairs plan for liver disease products utilizing internal resources and contract research organizations.
- Member of the International Medical Affairs Team responsible for establishing the regional plan and ensuring sharing and implementation of best practice.
- Ensure implementation of Standard Operating Procedures, guidelines, and departmental policies aligned to global.
- Ensure Medical Information is provided utilizing both the global system and local support.
- Manage early access programs prior to marketing authorization.
- Ensure post marketing commitments, e.g. patient registries, are complied with.
- Develop recommendations for Phase IV studies and be the conduit between the clinicians and Clinical Operations for Investigator sponsored trials.
- Act as the local primary contact point for the Italian Affiliate for Pharmacovigilance and Safety matters - working with both the local external Pharmacovigilance Partner, the EUQPPV and Corporate Pharmacovigilance and Safety Team QP, to ensure all Pharmacovigilance and Safety matters are appropriately dealt with, in accordance with local Country and EU safety requirements.
- Provide timely and well-informed guidance to broader activities, including but not limited to Health Technology Appraisals; business development opportunities.
- 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
- An MD (or equivalent degrees, e.g. MB ChB), with experience in hepatology, either gained through Industry experience or with appropriate postgraduate specialty training in hepatology and or gastroenterology, although experience in endocrinology or lipidology is also desirable. The individual will ideally have appropriate professional certification in both medicine (e.g. MRCP) and pharmaceutical medicine (e.g. MFPM, DipPharm Med or equivalent). Clinical and research experience in the key therapeutic areas is essential.
REQUIRED KNOWLEDGE AND ABILITIES:
- Most likely to be an experienced Medical Manager or Medical Director within Italy
- Demonstrated organizational skills encompassing the successful management of internal and external teams with both direct supervision and in a matrix team environment.
- Deep practical knowledge of Good Clinical Practices and the legal and regulatory requirements of working within a biopharmaceutical company across Europe.
- Entrepreneurial spirit.
- Recent experience in launching new innovation and supporting access for patients.
- Willingness to take initiative and become directly involved in planning, problem solving and execution of work in a team environment.
- Exceptional interpersonal skills and a collaborative management style.
- Demonstrated problem solving skills - including taking ownership to ensure timely resolution, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timetables.
- Strong verbal and written communications skills
- 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 and thrive in a growing, diverse and inclusive work environment
This is a unique opportunity to play a key role within a dynamic organization, where you will enjoy a high level of autonomy and a chance to work in an innovative therapeutic area.
To apply, please send a CV and cover letter in English no later than 6th April 2021