Senior Director, Clinical Program Lead - Stemline Therapeutics

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.

Matrix leader of cross-functional Clinical Program Team responsible for operation for assigned clinical program(s). Key accountability includes successful conduct of clinical trials consistent with applicable regulations, guidelines, and procedures, as well as managing clinical project timelines, budgets, deliverables, communications and serves as main point of contact for functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues.  Also may serve as the line manager of junior members of the Clinical Operations team (CTA, CRA, CPM).

Reporting to the Vice President of Clinical Operations, this role will be responsible for the clinical program management deliverables of assigned study(ies), in accordance with the agreed upon timelines, budget, and quality standards.

• Manages multiple clinical studies/projects in parallel, through direct reports and/or vendors.
• Manages all aspects of study execution, with or without a CRO, including operational plans and timelines to achieve on-time enrollment and study completion.
• Promotes effective partnership among cross-functional teams and provide day to day direction for core team. Leads problem solving and resolution efforts. Provides dedicated and creative recommendations on how to meet goals and handle identified risks.
• Assists in the process of protocol finalization, using expertise to optimize trial design and execution, including Identification of barriers to timely and successful study execution and propose solutions to same, with regular reporting of study performance metrics.
• Develops and coordinates operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug forecast, safety plan, monitoring plan, study management plan).
• Leads the Clinical Operation team(s) including in-house team members and Contract Research Organizations (CROs), vendors and other suppliers to ensure work quality, timeliness and adherence to budget.
• Acts as a line manager for the Clinical Trial Assistant, Clinical Research Associate and Clinical Project Manager. Responsible for managing performance and career development of direct and/or indirect report(s).
• Drives clinical trial database construction, data collection, and assists with audits of data to ensure data integrity.
• Manages CRO and site budgets, communicates deviations from budget projections, and propose solutions for budget deviations.
• Assists with management and execution of site training and ongoing educational interventions to assure compliance with study protocols.
• Develops and actively manages clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets.
• Assists with Clinical Operations financial planning/forecasting and budget management and monitor the budget against actuals.
• Assures compliance with regulatory requirements by monitoring overall study compliance of CRO’s, vendors, etc. with company standard operating procedures (SOPs), GCP, FDA and applicable international regulations.
• Meets with team members on a regular basis regarding project tasks to ensure project operational milestones are met.

Serves as primary project contact with vendors, including leading the proposal development and bid-defense process.

• 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, along with 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.
  
  

Stemline Therapeutics 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.

Salary Range: $200,000 - $260,000