Overview

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.

Responsibilities

Reporting to the Clinical Program Lead,  this role will be responsible to independently lead and oversee one or more global clinical trials and to deliver study outcomes within schedule, budget, quality/compliance and performance standards. 

 

Responsibilities

 

• Independent development of study related documents including but not limited to: protocol, case report forms, case report form completion guidelines, study manuals, project tools, project plans, tracking tools, and informed consent forms templates.
• Develops clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with line functions; ensuring vendors meet quality standards in their work for the trial; contributing to the development/amendment of vendor contracts.
• Oversees efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operation staff and departments as appropriate.
• Leads study management team meetings and teleconferences.
• Acting as point of contact for escalation of issues and creation of mitigation plans.
• Chair of the global cross-functional Clinical Trial Team (CTT), develop agenda and run meeting.
• Key contributor to the Data Review Plan; manages data flow and data cleaning process.
• Manages study-specific vendors, as appropriate.
• Supports the Clinical Program Lead with the development, management and tracking of the trial level budget(s) including forecast, and annual budget reviews. 
• Develops materials for trial advisory committees (e.g. Data Monitoring Committee, Steering Committee).
• Manages relationships to ensure successful delivery of all study lifecycle deliverables (RFP through completion of the trial).
• Ensures that the electronic Trial Master File (eTMF) maintained appropriately throughout the trial, including periodic reviews.
• Contributes to operational excellence through process improvement and knowledge sharing.
• Participates and responds to Quality Assurance and/or regulatory authority inspection audits, responsible for identifying and implementing corrective action and risk mitigation.
• Ability to collaborate with other departments to meet study timelines and goals.
• May serve as line manager to one or more Clinical Trial Assistants.  Provides guidance and mentorship to the Clinical Trial Manager and Clinical Trial Assistant.
• Supports of departmental functions and attends departmental meetings.

Qualifications

• BS/BA degree in a scientific or health related discipline. Advanced scientific or equivalent experience preferred.
• Minimum of 10 years experience in drug development, clinical research and operational strategy including responsibility for ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred).
• Small biotechnology company experience a plus.
• Demonstrated project/program management skills including risk assessment, timeline and budget management and contingency planning.
• Line management experience including talent identification, development, coaching, performance management and resource allocation.
• Effective team leadership of matrix teams.
• Excellent communication, management and organizational skills, problem-solving, conflict resolution, and team building skills.
• Experience across several complex therapeutic areas.
• Experience planning and delivering US-based and global clinical programs and studies
• Multi-study experience managing early through late-stage clinical trials.
• Working knowledge of, and experience with, clinical trial conduct, GCPs and FDA Regulations.

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.

 

Please note--this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

 

Base Salary Range: $150,000-$220,000, commensurate with level and experience

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