Menarini Stemline

Overview

Regional Clinical Science Liaison, North America

Reports to Senior Director, Clinical Development & Medical Affairs

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.

Responsibilities

The Regional Clinical Science Liaison (CSL) plays a pivotal role in advancing breast cancer clinical trials at Menarini Stemline by cultivating robust relationships with clinical trial sites and investigators, with a primary focus on optimizing patient enrollment. This role necessitates close collaboration with clinical trial sites and cross-functional teams, including Clinical Research Associates (CRAs), Field Medical Affairs, Project Managers, and Medical Monitors, under the guidance of a Senior Director in Clinical Development.

Responsibilities

• Site Engagement and Relationship Management:
• Identify and evaluate potential clinical trial sites and investigators specializing in breast cancer, ensuring alignment with study protocols and patient eligibility criteria.
• Build and sustain strong relationships with investigators, site staff participating in breast cancer trials
• Serve as the primary point of contact for site inquiries related to recruitment and enrollment, providing timely and accurate information.
• Facilitate seamless communication and collaboration between sites and the study team to align recruitment objectives and strategies.
• Recruitment Strategy and Support:
• Collaborate with sites to develop and implement effective patient recruitment strategies tailored to breast cancer studies, considering patient demographics, tumor characteristics, and current treatment paradigms.
• Provide expert guidance and support to sites facing recruitment challenges, leveraging knowledge of breast cancer patient advocacy groups, support organizations, and relevant medical conferences.
• Proactively monitor site enrollment progress in partnership with the study team to identify and address potential roadblocks or inefficiencies.
• Collaborate with CRAs to ensure smooth study conduct and resolve any recruitment-related issues in breast cancer trials.
• Trial Education and Scientific Communication:
• Deliver accurate and current information regarding the company's breast cancer pipeline products to healthcare professionals through various channels, including one-on-one meetings and scientific presentations
• Support site initiation activities, including comprehensive training on breast cancer-specific recruitment procedures and providing essential study materials, providing updates on protocol amendments.
• Support organizing regional Investigators’ meetings
• Actively gather insights from healthcare professionals concerning study protocols, site-specific requirements, and the evolving breast cancer treatment landscape, informing the company's research and development strategies.
• Compliance and Quality Assurance:
• Maintain a thorough understanding of relevant regulations, GCP, and ICH guidelines pertaining to clinical trial conduct and patient recruitment, with a specific emphasis on breast cancer research.
• Ensure all recruitment activities adhere to ethical standards and applicable laws and regulations.
• Participate in ongoing training to enhance expertise in breast cancer research, treatment advancements, and best practices in patient recruitment.
• Escalate any site concerns or issues to the Clinical Development team and Senior Director for timely resolution.
  

Qualifications

Skill/Knowledge Requirements

• An advanced degree in a life-science field (MD, Ph.D. or Pharm.D.) is preferred.
• Minimum of 5 years of experience in clinical research, with a strong focus on breast cancer clinical trials.
• In-depth knowledge of breast cancer, including disease subtypes, staging, treatment options, and the current research landscape.
• Experience in site management, monitoring, or recruitment, strong understanding of clinical trial operations, GCP, and ICH guidelines.
• Excellent communication, interpersonal, and presentation skills, with the ability to clearly articulate complex scientific concepts.
• Proven ability to build and maintain strong relationships with key stakeholders.
• Strong organizational and time management skills, with the ability to prioritize tasks effectively.
• Ability to work independently and collaboratively within a team.
• Willingness to travel up to 60% or more as needed covering clinical trial sites across multiple territories
  
  

Base Salary Range of $180,000 - $230,000 plus 25% annual bonus & 35% Long-term Incentive Bonus. Menarini Stemline offers generous compensation and benefits packages, including, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

Menarini Stemline is 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. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions