Senior Clinical Trial Manager

Overview

Senior Clinical Trial Manager

Global Clinical Operations

Remote, US

Opportunity

The Senior Clinical Trial Manager will be responsible and accountable for the development of clinical trial operational strategy and leading planning execution of day-to-day study operations, leading the cross-functional Clinical Trial Team (CTT), managing outsourced Contract Research Organization (CRO) and third party vendor activities, and being accountable for adherence with overall clinical trial timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs).

Responsibilities

• Manages efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operation staff and departments as appropriate.

• Designs or assists in the development of study related documents including but not limited to: protocol, case report forms, case report form completion guidelines, study manuals, project tools, project plans, tracking tools, and informed consent forms templates.

• Contributes to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); manages interface with CROs in cooperation with line functions; ensures vendors meet quality standards in their work for the trial; contributes to the development/amendment of vendor contracts.

• Acts as initial point of contact for all site-related issues and procedural questions.

• Core member of the global cross-functional Clinical Trial Team (CTT); reports study progress and issues/resolution plan at the CTT meeting; writes CTT meeting minutes. Organizes and chairs trial sub teams within the scope of his/her delegated responsibilities.

• Defines the Data Review Plan; ensure clinical trial data is cleaned to ensure scientific excellence.

• Manages study-specific vendors, as appropriate.

• Supports the Clinical Trial Lead/Program Lead with the development, management and tracking of the trial level budget including forecast, and annual budget reviews.

• Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee).

• Manages relationships to ensure successful delivery of all study lifecycle deliverables (RFP through completion of the trial).

• Ensures that the electronic Trial Master File (eTMF) is maintained appropriately throughout the trial, including periodic reviews.

• Contributes to operational excellence through process improvement and knowledge sharing.

• Participates and support response to Quality Assurance and/or regulatory authority inspection audits.

• Ability to collaborate with other departments to meet study timelines and goals.

• Provides guidance and mentorship to Clinical Trial Managers and Clinical Trial Assistants.

Supports departmental functions and attends departmental meetings.

Qualifications

• Minimum of BA/BS degree or equivalent in relevant discipline (scientific background is preferred). Advanced degree is preferred.

• Minimum of 8 years of experience in clinical research with a sponsor company or CRO

• Oncology experience is required.

• Understanding of clinical development within one or more Phases of trials (Phase I, II, and III).

• Scientific learning agility to quickly develop a sound working knowledge of the therapeutic area.

• Ability to manage various activities associated with multiple clinical studies in accordance with designated project assignments.

• Understanding of basic biological principles in oncology required.

• Excellent knowledge on ICH/GCP, FDA-CFR.

• Able to communicate effectively.

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.

Base Salary Range of $192,000 to 206,000 plus bonus and long term incentives. Menarini Stemline offers generous compensation and benefits packages, including bonus and long-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

Menarini Stemline is 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.

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

The Company

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.

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.