Director, U.S. Patient Journey

Reports to Executive Director & Head, U.S. Patient Advocacy

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 140 countries 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 hematological and solid tumors. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. ELZONRIS® (tagraxofusp) is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). To date, Elzonris is 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 leukemia (AML), chronic myelomonocytic leukemia (CMML), and myelofibrosis (MF).

In Europe, Menarini Stemline also commercializes Nexpovio®, a first-in-class oral exportin 1 (XPO1) inhibitor for multiple myeloma in the UK, Switzerland, European Economic Area, CIS countries, Latin America and Turkey. Nexpovio is approved for use in combination with dexamethasone for treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy; and in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy. Nexpovio’s marketing authorization is valid in the EU Member States as well as Iceland, Liechtenstein, Norway, and Northern Ireland, and it has been commercially available in Germany and Austria since the fourth quarter of 2022.

In January 2023, Stemline Therapeutics, received U.S. FDA approval for ORSERDU™ (elacestrant), the first and only treatment specifically indicated for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. ESR1 mutations cause tumors to become resistant to endocrine therapy, and up to 40% of patients with ER+, HER2- mBC have tumors which harbor this mutation. ORSERDU is the first endocrine innovation in more than 20 years, and specifically addresses a major unmet need. Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. A Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA).

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 Tumor 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 is offering 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.

Opportunity

Menarini Stemline is creating a new position: Director, U.S. Patient Journey, responsible for executing the company’s oncology patient relations work. Importantly, successful candidates will possess excellent writing and presentation skills, pay sharp attention to details, and possess the ability to carry out multiple tasks while maintaining adherence to rigorous quality standards. Competitive candidates will possess 6-8+ years of significant, relevant experience in patient relations and/or patient engagement, with a demonstrated ability to cultivate positive relationships with patients on behalf of the company.

The ideal candidate should enjoy working in a high energy, ever-changing work environment, with highly motivated and passionate people, while maintaining composure in a fast-paced environment, and interfacing comfortably with the executive leadership team when needed.

• Play a key role in developing and implementing the patient relations plan for Menarini Stemline’s oncology products and pipeline, with a core focus on our newly approved treatment for metastatic breast cancer, ORSERDU™
• Represent the company at external patient group meetings and conferences, and provide high-level PRC-approved information and resources to patients
• As a member of the Patient Advocacy Team, support the team’s efforts to engage metastatic breast cancer patients through initiatives such as: patient education events and materials, awareness programs, online patient engagement tactics, and other related projects as needed
• Cultivate a corps of patient ambassadors to share their stories of living with metastatic breast cancer
• Liaise with patients from the disease communities served by Menarini Stemline’s other oncology products and pipeline, as needed
• Prepare internal reports as needed to convey information, patient insights and issues, and community feedback that may affect company operations and brand plans
• Collaborate directly with internal staff including, but not limited to: Medical Affairs, Clinical Development, Marketing, Market Research, Sales, Reimbursement and Patient Assistance Programs; ensure cross-functional alignment and the incorporation of the patient perspective in multi-departmental working groups
• Help drive positive community awareness around Menarini Stemline as a patient-centric leader in oncology
• Ensure high quality patient materials are produced in a timely manner and free of error
• Keep abreast of new developments and ideas in the field of patient relations and incorporate such developments, ideas, and strategies into the execution of our patient engagement programs in support of Menarini Stemline and its pipeline
• Coordinate the regulatory, legal and medical review process of all advocacy communications materials
• Liaise directly with various outside groups, including current or prospective vendors, our advertising, PR and advocacy agencies, and other consultants
• Coordinate Menarini Stemline’s grants for patient education and programming, ensuring alignment with our strategic focus while following all compliance guidelines
• Provide support to the Executive Director of U.S. Patient Advocacy with budget management and coordinate related tasks
• Maintain confidentiality as it pertains to sensitive scientific data, HIPAA protected patient information, and other designated topics, at all times

Required Qualifications & Experience:

• College degree, as well as 6-8 years’ experience in patient relations with an exemplary track record
• Excellent strategic thinking skills, and a successful record of aligning patient engagement initiatives to the company’s over-arching strategic imperatives to drive results
• Experience in the oncology space is required; women’s health experience is a plus
• In-depth knowledge of oncology patient associations and the overarching cancer patient landscape
• Robust knowledge of current compliance, legal, regulatory, and other issues that impact the biopharmaceutical industry and its patient engagement and advocacy practices
• Ability to anticipate and plan for potential issues, threats, and concerns regarding our business and pipeline, as well as the skills to address emerging issues immediately
• Superb communicator, including excellent writing, editing, and presentation skills; must exhibit tact, composure, and confidentiality in order to manage sensitive information and participate in key inter-departmental interactions
• Superior organizational and budgeting skills; detail-oriented
• Ability to comfortably and appropriately interact with the executive team as needed
• Proven capacity to implement, monitor, and logistically manage strategic plans in support of the company’s initiatives; while agency support will be available, Menarini Stemline is a hands-on environment so candidates must be capable of rolling up their sleeves to get the work done
• Ability to travel approximately 25-30% of the time, including on weekends, as needed
• A positive mental attitude and team orientation; resilient/flexible in the face of changing demands