Manager, Study Start-up & Site Contracts

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 Study Start-up and Site Contracts Manager will support the GCO organization to expedite site start-up and contract execution in close collaboration with internal and external stakeholders, vendors, and investigator sites.

Responsibilities             

Problem-solving

• Proactively identify potential roadblocks and challenges in the study start-up process, including site feasibility, regulatory concerns, contract discrepancies, and site activation delays.
• Develop and implement creative solutions to overcome complex study start-up issues, utilizing strong analytical skills to assess root causes and propose effective mitigation plans.
• Collaborate with clinical research sites to address site-specific challenges, providing guidance on protocol interpretation, regulatory compliance, and study documentation; meanwhile, assist in negotiating clinical trial agreements (CTAs) with research sites, ensuring favorable terms regarding study budget, timelines, and deliverables.
• Effectively communicate study start-up issues to relevant stakeholders including study team members, site investigators, and project management, facilitating timely decision-making and problem resolution.
• Identify opportunities to optimize study start-up processes, including developing new workflows, standardizing procedures, and implementing technology solutions to enhance efficiency.

Contract Management

• Ensures the timely and successful negotiation and on-going management of clinical trial agreements with investigative sites.
• Works cross-functionally across Clinical Development, Medical Affairs, Regulatory Affairs, and Program Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.
• Collaborates with the Functional Manager who will partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials
• Communicates and explains legal/ budgetary issues to internal and external parties per department guidelines.
• Reviews and evaluates client requested contract changes and based upon department guidelines escalates deviations as appropriate.
• In partnership with Clinical Operations team, and others as necessary, evaluates priorities and quickly readjusts priorities with the changing needs of business and the client.
• Identifies and proactively raises issues to the Clinical Trial Lead or Clinical Trial Manager, as appropriate, prior to their becoming critical and manages risks with clear mitigations
• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.
• Initiates meetings for the purpose of expediting the contract signing process as directed. Tracks all site interaction in a timely and accurate manner and ensures that status updates are fully descriptive May track and create files for all contracts.

Study Start-up

• Leads internal SSU team meetings and develop site initiation plans and collaborates with the clinical trial team as required.
• Support study start-up strategy in collaboration with key stakeholder and ensure timely start-up activities from site selection to activation
• Either directly or overseeing a CRO, collaborate with local IRBs/ECs and Health Authorities as necessary and prepare IRB/EC submission packages and review Informed Consent Forms.
• Coordinate timely responses to deficiency letters and reportable events and ensure quality and compliance of Trial Master File documents in study start-up.
• May support to oversee vendor performance to achieve start-up timelines and quality execution.

Skill/Knowledge Requirements

• Bachelor’s Degree or international equivalent, legal background or education preferred
• Minimum 5 years in the role, 2-4 years’ Experience with contracts.
• Thorough understanding of clinical trial methodologies, regulatory guidelines (e.g., GCP, ICH), and study start-up procedures. 
• Proven ability to analyze complex situations, identify root causes, and develop effective solutions to resolve study start-up challenges. 
• Excellent written and verbal communication skills to effectively interact with diverse stakeholders, including site investigators, study team members, and vendors. 
• Experience in negotiating clinical trial agreements with research sites to achieve favorable terms for the study preferred
• Ability to manage multiple projects simultaneously, track progress against timelines, and identify potential risks to ensure study start-up milestones are met.
• Ability to work effectively in a matrixed environment.

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.