Director, Clinical Value and Evidence Liaison

Overview:

Director, Clinical & Value Evidence Liaison

Reports to Executive Director, Clinical Value & Evidence Liaison

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 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. 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 leukemia (AML), chronic myelomonocytic leukemia (CMML), and myelofibrosis (MF). 

Additionally, Menarini received exclusive rights to commercialize 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 commercialize 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 tumors. It is already marketed in the US for multiple myeloma and is under development for solid tumor indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global license 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 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 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 following 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.

SUMMARY 

The Director, Clinical & Value Evidence Liaison is a field-facing role within Medical Affairs whose main objective is to be a trusted scientific partner to key external payer and other population health decision-maker (PHDM) experts by conducting timely, appropriate scientific exchanges to enhance the understanding of the scientific and clinical value of Menarini Stemline products. In addition, the Director, Clinical & Value Evidence Liaison will develop opportunities to partner with PHDMs in a collaborative research project capacity, meeting shared goals and objectives. External customers include Managed Care Organizations (MCOs), large physician groups, health systems, Group Purchasing Organizations (GPOs), Pharmacy Benefit Managements (PBMs), Governmental Agencies (VA/DoD System), Medicare, Integrated Delivery Networks (IDNs) and Oncology Clinical Pathway Developers in the assigned region/geography.

The Director, Clinical & Value Evidence Liaison is responsible for supporting and partnering with key internal business partners, primarily colleagues in Market Access that have field responsibilities. This individual will contribute to business planning and internal business partner teams by providing strategic clinical and health outcomes input along with customer insights. They will maintain a high level of key account management and build external relationships with recognized experts in managed markets/healthcare systems.

This individual has a proven leadership track record with exceptional communication, collaboration and prioritizing skills. They will support pre- and post-launch activities. As part of the Medical Affairs team, this position contributes to and supports the company's efforts in communicating the high value of Menarini Stemline products to address unmet medical needs. They also support evidence generation through real-world evidence (RWE) initiatives.

• Sustains expertise in disease state management, emerging therapies, and competitor products
• Develops and maintains expertise in the ever-evolving US healthcare landscape management and delivery
• Understands dynamics of the health plan’s/PBM’s formularies and positioning of Menarini Stemline product(s) and ways to deliver and enhance product value propositions to optimize market access from a scientific data perspective
• Possesses and develops ongoing expertise in the scientific domains of health economics and outcomes research (HEOR) and real-world evidence (RWE) and their role in developing value propositions for medical interventions
• Collaborates with cross-functional partners in Account Management, Payer Marketing, Commercial Sales, and Clinical Development, to effectively communicate the scientific narrative and value proposition of Menarini Stemline products to critical PHDMs
• Manages project work related to Medical Affairs activities and effectively collaborates with cross-functional partners as assigned, including participation in various initiatives related to scientific and strategic objectives; collaborating with other functional teams; and helping to realize departmental workstream efficiencies
• Builds relationships with Medical Science Liaisons (MSLs) and other cross-functional partners in Market Access and Marketing to understand regional External Expert thought processes that may facilitate health plan decision-making, and partners with them in field engagements, as appropriate
• Consistently adheres to internal standard processes and comply with regulatory and compliance requirements
• May travel up to 60%
• Other duties as assigned

CORE FUNCTION – SCIENTIFIC EXCHANGE

• Provides clinical support and delivers data presentations regionally and nationally as needed for the population health decision-maker (PHDM) audience
• Represents and supports Menarini Stemline at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards, and investigator meetings
• Captures and documents key insights from PHDMs and analyzes insights into meaningful action items for the organization
• Identifies, understands, and acts on unmet needs of prioritized PHDM stakeholders and utilize clinical evidence and economic models that differentiate Menarini Stemline product(s), as able
• Provides medical/scientific expertise in the development of content and programs to be used for educating internal support functions and key internal stakeholders
• Actively participates in select medical/outcomes research meetings, advisory boards, and internal meetings with the goal of developing and implementing strategic clinical programs in conjunction with the internal Clinical Development team to impact current and future research strategy and designs, as well as current and future value propositions of both Menarini Stemline commercial and pipeline products
• Contributes to the development, management, and execution of the Medical Affairs Strategic Plan and all related pre- and post-launch activities

CORE FUNCTION – HEOR/RWE Research

• Develops and executes opportunities to partner with PHDMs in payer and institutional settings in data-centric projects (e.g., real-world evidence [RWE] and/or quality improvement [QI] initiatives)

• An advanced degree required (e.g., PharmD, DNP, PhD or MD); additional master’s degree in scientific research domain preferred (e.g., MS, MPH)
• Generally, 5-7 years of relevant experience, which includes 2+ years working as a Health Economics Outcomes Research (HEOR) Liaison in the biotech/pharmaceutical industry or a combination of experience working within a payer organization and as a HEOR Liaison; also includes 2+ years with direct HEOR/RWE project experience
• Preferred knowledge or experience in the Oncology therapeutic area with experience in Breast Oncology preferred
• Basic knowledge of payer quality and performance measures
• Basic knowledge of health system incentives around pharmaceuticals (e.g., infusion vs oral agents, medically integrated dispensing)
• Familiar with health economics, outcomes research, disease management and practice/pathway guidelines and methodologies, comparative effectiveness research and trends; able to relate these developments to pharmaceuticals
• Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills
• Experience working with cross-functional medical, market access, and commercial teams is required
• Experience planning and executing HEOR and/or real-world evidence research projects
• This role requires excellent verbal and communication skills in multiple settings and the ability to manage multiple activities and projects and prioritize activities accordingly
• Exceptional interpersonal and leadership skills to effectively communicate and build relationships with a broad spectrum of audiences at all organizational levels
• Solid analytical and strategic capabilities and business acumen along with demonstrated work ethic, integrity, and professional conduct
• Candidates must be strong team players, take initiative (roll up your sleeves attitude), think strategically and creatively.
• Must possess excellent project management skills
• Strong Microsoft Office Suite (Excel, PowerPoint, Word) skills
• Ability to travel, locally and regionally, up to 60% with overnight stays (e.g., Payer meetings, payer/institution locations, internal meetings, medical meetings, congresses, and training).

Required Travel: Up to 60% may be required.

Location: Remote

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Base salary range: $200,000-$235,000