Clinical Business Operations Manager

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 Clinical Business Operations Manager is a strategic role within the R&D GCO organization, dedicated to driving operational excellence across clinical trials. The Clinical Business Operations Manager (CBOM) acts as a primary point of contact for all vendors and GCO business partners for their therapeutic & functional areas of support across the portfolio. CBOM will collaborate with clinical program directors, clinical program leads, clinical trial leads, finance, procurement & strategic sourcing, legal, and other internal stakeholders to secure services for our clinical trials and drive the governance and overall management of their scope of work.    

Responsibilities             

• Influences and strategically manages the linkages between GCO across functional areas, including finance, project management, data management, PK, biostatistics, clinical development, medical affairs, regulatory, drug supply, pharmacovigilance, translational, CMC, and QA to drive the successful implementation of the outsourcing strategy for an assigned project or program
• Work closely with Finance and clinical program team to closely monitor scope of work, vendor budgets, out-of-scope activities, accrued units or milestones, and tracking of vendor payments.
• Acts as the first line of contact for issue escalation related to contracts and budgets. 
• Provides training of internal stakeholders on key contractual terms and obligations to ensure compliance and understanding as the business partners execute the work performed under the contract
• May independently lead the RFP and RFI process, analyze supplier services, budgets and proposals, conduct bid defense meetings, award vendors, negotiate and execute complex agreements
• Cultivate and maintain strategic partnerships with Contract Research Organizations (CROs) and other vendors to optimize timelines, budgets, and quality across the portfolio.
• Independently identifies, escalates and manages non-preferred provider vendor performance issues and develops and implements solutions to ensure overall performance, compliance, and quality.
• Partner with functional leaders to drive alignment across the clinical trial portfolio, ensuring strategic priorities are consistently met.
• Driving a culture of innovation and operational excellence, ensuring the clinical operations function remains at the forefront of industry’s best practices and emerging trends.
• Provide effective communication and recommendations to the business with support from the SME to ensure Menarini Stemline receives the best value for the contracted service. Accountable for the development and successful execution of the contract implementation plan which includes implementing the sourcing strategy to ensure timelines are met while maintaining compliance with all applicable policies and procedures.
• Actively monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization utilizing advanced knowledge to drive the negotiation of the change orders and associated costs to minimize the risk to Menarini Stemline. Manages expectations and mitigates risk by providing strategic solutions for issues and executes final agreements/change orders with minimal guidance and support.
• May lead or contribute as a subject matter expert on key projects, initiatives, and committees including governance vendor meetings to identify and implement process improvements and standards while ensuring Menarini Stemline’s business needs and purchasing/compliance requirements are met.
• May oversee the selection, implementation, and management of key clinical technologies (e.g., project accounting tool.

Qualifications

• BA/BS or equivalent related work experience is required; Degree in healthcare, legal and/or finance preferred.
• Minimum 6 years of extensive experience in research, industry or legal setting with pharmaceutical industry experience in clinical outsourcing contracting or finance is required.
• Must have demonstrated ability in negotiation and project management skills with the ability to coordinate across projects/program/timelines.  Must have superior written and oral communication skills, with the ability to convey overall engagement objectives and maintain open lines of communication between the internal stakeholders and the service providers.
• Ability to build internal and external relationships to effectively and independently provide leadership and mentor other team members to strategically drive the business and solve issues efficiently and mitigate risk.

Skill/Knowledge Requirements

• Proven experience selecting and managing, and overseeing CROs, vendors, and clinical trial consultants.
• Demonstrated expertise in forecasting, budgeting, data analytics, modeling, and process improvement design.
• Strong project management skills and the ability to lead cross-functional teams in a matrixed environment.
• Experience with technology implementation and operational transformation within clinical trials.
• Demonstrated success in scaling operations within a fast-paced, entrepreneurial biotech or pharmaceutical setting.
• Strong analytical skills with the ability to synthesize complex data and communicate actionable insights.
• strong interpersonal skills with demonstrated ability to connect, collaborate and build relationships across all levels and functions and establish credibility with leaders and key external stakeholders
• strong oral and written communication skills with ability to communicate effectively at all levels and present complex and/or new ideas both internally and with external stakeholders
• extensive knowledge of GCP and ICH principles of clinical trial conduct
• strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint).

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.