Senior Director, Global Clinical Systems & Excellence (GCSE)

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 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.

Opportunity

The Global GCSEClinical Systems and Excellence  is a function that belongs to the Global Clinical Operations (GCO) Organization and is responsible for driving and monitoring clinical compliance, inspection readiness, tracking and reporting performance metrics, managing processes and procedures, vendor sourcing, and management of the Trial Master Files .

As the Head of Global Clinical Systems and ExcellenceGCSE, you will support the Head of Global Clinical Operations. You will manage GCSE team’s priorities, overseeing internal operations, leading/project managing key projects, and driving culture initiatives. This role will focus on designing, implementing, and deploying a robust GCSE strategy concerning operations and planning that will support Menarini Stemline’s current expanding portfolio and compliance needs. 

You will be an active and engaged leadership team member. You will be flexible and able to adapt to the changing needs of the organization, working together with the Global Clinical Operations head to drive continuous improvement in communication, innovation, and process simplification within the Global Clinical  Operations team and across the matrixed cross-functional organization, anticipating issues, formulating solutions and ensuring deadlines are met are core responsibilities. 

This role will be responsible for ensuring that key projects and initiatives are progressed quickly and to a high standard – while also driving a collaborative culture and striving to achieve strong cross-functional relationships and alignment with senior level stakeholders, data-driven decision-making, and operational excellence in delivery. 

Responsibilities

• Serve as a trusted leader responsible for matrix managing the administrative and strategic functions of GCSE operations and planning. 
• Collaborate with cross-functional leaders to proactively develop fit-for-purpose strategies and scalable processes and solutions that enable consistent, timely and efficient delivery of the portfolio. This includes the operational and technology roadmaps for clinical operations, data management and statistics, aligning with organizational goals.
• Oversee the selection, implementation, and management of key clinical technologies (e.g., TMF, EDC, statistical tools), ensuring compliance with regulatory requirements and integration into portfolio-level study execution.
• Cultivate and maintain strategic partnerships with Contract Research Organizations (CROs) and other vendors to optimize timelines, budgets, and quality across the portfolio.
• Act as an advisor and report to the Head of Global Clinical Operations and present to the senior leadership team 
• Shape TMF Operations throughout the lifecycle of clinical trials from eTMF implementation, audits, and to regulatory inspections and archiving
• Ensure functional compliance with Company TMF SOPs, KPIs, relevant TMF process-supporting guidance, and applicable global regulations
• Perform risk-based quality control (QC) and monitor internal/external KPIs
• Drive performance of CROs against relevant Company TMF SOPs and TMF-related processes and procedures (e.g., Study Specific TMF plan)
• Acts as the liaison between the GCSE, other executives, and stakeholders to ensure consistent communication and ensuring involvement or decision-making in a timely manner. 
• Ensure timely and effective completion of strategic projects and initiatives. 
• Create and maintain systems, business processes and metrics to streamline operations within GCSE, and to support GCO across the organization. 
• Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents
• Ensure Meeting Effectiveness: Drive agenda setting and allocate time appropriately across topics, provide context to agenda topics, and draft post-meeting minutes and assuming responsibility for follow-up actions 
• Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization
• Ensure quality risk management principles are integrated in all Global Clinical Operations processes and systems in order to support compliance and ensure inspection readiness throughout
• Lead initiatives and continuous improvement related to business operations, including establishing best practices and assessing key performance metrics 
• Interface regularly with members of the clinical science group (clinical operations, data management and DMPK groups) and other senior leaders. Supporting and driving corporate and enterprise strategy in concert with these leaders will be critical in this role. 

Skill/Knowledge Requirements: 

• Great project management skills - organized, disciplined, comfortable following up on actionable /holding people accountable, able to think ahead and catch problems before they arise 
• Adaptable, strong listener, comfortable providing feedback 
• Strategic thinker – able to consume large amounts of information, build strategy and communicate key priorities 
• Understands their role of “leading from behind” and leans into this 
• People Oriented - high emotional intelligence, relationship builder, empathetic, works well with different people types 
• Strong Communication skills - clear verbal and written communicator, summarizes information succinctly, able to adapt communication to different audiences 
• Strong PowerPoint creation skills 
• Outstanding time management and experience at performing in the context of a fast-paced biotech, multicultural, global organization where working across boundaries and leading through influence are keys to success
• A deep understanding of systems and processes that support clinical trial execution, harnessing efficiencies and standards that enable business success
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)
• Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact

Education Required:  

• Bachelor’s degree with 12+ years of relevant experience or master’s degree with 9+ years of relevant experience. 
• PMP Certification is a plus
• Fluency in English (verbal and written) required; other languages are a plus. 
• Clinical Operation Experience

Other Qualifications:    

• Willingness and ability to both manage projects and execute tasks in accordance with business needs. 
• Ability to lead colleague engagement across an organization. 
• Strong leadership, organizational, team development and communication skills. 
• Ability to handle confidential and proprietary information using excellent discretion and judgment. 
• Self-motivated, able to work independently and be reliable and responsive. 
• Ability to be flexible and willing to accept new responsibilities as needed.

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.