Senior Director, Global Collaborative Research, Hematology

Stemline Therapeutics; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

Stemline Therapeutics, part of the Menarini Group, is seeking a Senior Director for Global Collaborative Research in Haematology. In this role, you'll manage independent and collaborative research portfolios, ensure adherence to regulations, and support the advancement of our innovative oncology initiatives. Join us in shaping the future of cancer treatment with your expertise in a dynamic and inclusive environment.

Qualifications

• Minimum of 5 years experience in clinical research or pharmaceutical/biotech industry.
• Experience in Haematology/Oncology research management preferred.
• Global experience in research study execution essential.

Responsibilities

• Oversees global hematology collaborative research initiatives.
• Drives study start-up activities and manages project milestones.
• Collaborates with cross-functional teams to ensure compliance and optimize processes.

Skills

Scientific agility

Critical thinking

Communication skills

Education

Bachelor’s degree in life sciences or healthcare

Tools

Microsoft Office

Job description

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

The Senior Director, Global Collaborative Research, Haematology is accountable for the management and oversight of Menarini Stemline’s haematology collaborative research portfolio, encompassing independent (e.g. ISR, IIT, ISS, IIS, etc.) and collaborative interventional and non-interventional studies. This is a highly collaborative role, providing study, project, and program support to internal stakeholders, cross-functional departments, and external sponsor teams. This individual will be responsible for the lifecycle (e.g. start-up through close out) of their portfolio of studies, ensuring that Menarini Stemline adheres to all applicable SOPs, laws, regulations, and best practices in the execution of our research program.

Key Responsibilities:

• Independently manages and provides oversight for all components of Menarini Stemline’s global hematology collaborative research portfolio, encompassing independent and collaborative scientific research initiatives
• Participates in the Medical Affairs Research Committee (MARC) and related governance meetings, ensuring that decisions rendered are carried out within the new and existing portfolio
• Drives study start-up activity for Menarini Stemline, including protocol review, contracting, financial set-up, document collection, drug supply set-up, and ultimately study activation
• Monitors and tracks activities and key milestones on individual studies throughout their lifecycle, summarizing this information for any relevant reporting, cross-functional communication, and stakeholder awareness
• Monitors and manages individual study budgets for assigned portfolio
• Collaborates with Information Technology, Quality Assurance, Compliance, and other departments to optimize systems, processes, policies, and standard operating procedures
• Develops and maintains relationships with external collaborators, including healthcare professionals, healthcare organizations, research organizations, site staff, and other supporting roles
• Supports the growth and evolution of Menarini Stemline through the development of novel or best practice solutions to problems of large or small scale
• Escalates issues proactively, recommending and implementing innovative processes to address and improve identified difficulties
• Supports the development of action plans that address compliance, safety, and administrative issues, both internally and externally

Qualifications

• Bachelor’s degree or equivalent, preferably in life sciences or healthcare field
• Minimum of 5 years of relevant experience in an academic clinical research setting and/or pharmaceutical/biotech industry, preferably in medical affairs research operations or clinical operations
• Experience managing independent or collaborative research in Haematology/Oncology or a related field
• Global (e.g. US, EU, LATAM, APAC, etc.) experience in the planning, launching, maintenance and closure of interventional and non-interventional studies, including relevant knowledge of CFR, ICH GCP, contracting standards, and GDPR/data privacy requirements
• Self-starter comfortable working in a virtual environment with cross-functional teams in a variety of geographies
• Scientific agility with ability to summarize complex scientific or medical terms to a broad audience
• Resourceful with keen critical thinking skills; ability to utilize available resources to drive solutions
• Ability to prioritize urgent and important tasks and take necessary actions to inform or escalate to management and stakeholders as necessary
• Ability to influence and work effectively across functions and operate in a complicated and evolving matrix environment
• Must possess excellent oral and written English communication skills, including presentation skills
• Basic technical and electronic skills, such as databases, systems, and Microsoft Office computer programs

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.

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