Overview
Job title: Global Market Access and Reimbursement Product Lead (GMARPL), Solid Tumors
Reports to: Global Market Access & Reimbursement Franchise Lead, Solid Tumors
Opportunity
We are looking for a self-motivated and experienced GMARPL to join our team and contribute to our global access product strategy initiatives. The GMARPL will be responsible for supporting the development and implementation of market access strategies, ensuring the access country affiliates have everything needed to secure favorable access of our products.
The role will require deep understanding and appreciation of the relevant access routes, pricing, reimbursement mechanisms as well as a sound scientific, technical, regulatory, and commercial expertise to support reimbursement efforts globally.
Responsibilities
- Responsible for the development and execution of market access strategies for a specific brand, ensuring alignment with program and brand strategies to optimize brand value and market access.
- For products entering full development prior to regulatory approval, establish an understanding of the burden of disease, unmet need, and work with the RWE lead on a plan for evidence generation to support the value of the product in clinical, economic, and humanistic terms to optimize pricing and reimbursement. For in-line product brands, support and enhance product value propositions.
- Development, execution, and update of global market access tools (i.e., global value dossier) to ensure pricing and market access.
- Differentiate our products by supporting the markets to adapt or evolve a global value story to a local healthcare context to maximize our products' value.
- Assist country affiliates in their reimbursement negotiations by integrating country-specific needs into pricing and HEOR strategy, and by preparing other relevant information such as training on materials and pricing and negotiation workshops.
- Collaboration with the GVEEA team (HEOR, RWE, pricing), including commercial, and medical organisations as applicable.
Qualifications
- University degree, MBA or PhD in science and/or economics or related field desirable.
- A minimum of 7 years of pharmaceutical industry experience and 3 years in a global / regional market access function.
- Understanding of breast cancer disease highly desirable.
- Experience in pricing and reimbursement in Europe (a must) and RoW at the country and regional level.
- Experience working on global projects involving cross-functional teams and product launches.
- Strong analytical capabilities and ability to draw conclusions, with excellent written and communication skills.
- Excellence in execution, acts with a sense of urgency, and ability to deliver high quality work under tight timelines.
- Demonstrated ability to work cross-functionally and out of the box thinking.
- Fluent in English (second language desirable).
Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees
The Company
Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.
The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.
Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.
Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).
Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.
Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.
Menarini’s commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB’s CELLSEARCH Circulating Tumour Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.
Since 2021, MSB has offered in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient’s therapeutic journey.
In 2022, the company launched the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.
Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management.
It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.
