Clinical Trial Lead

Overview

Clinical Trial Lead

Remote US

Opportunity

Lead the planning, execution and oversight of designated clinical studies, from initiation through study closure. Ensure compliance with quality standards, regulatory requirements, timelines, and budget commitments.

Responsibilities

Main Tasks

• Independent development of study related documents including but not limited to protocol, study manuals, project tools, project plans, tracking tools, and informed consent forms templates.
• Develops clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with line functions; ensuring vendors meet quality standards in their work for the trial; contributing to the development/amendment of vendor contracts.
• Oversees 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.
• Leads study management team meetings and teleconferences.
• Serves as main study contact for the cross functional team, CROs, vendors (as applicable) and acts as point of contact for escalation of issues and creation of mitigation plans.
• Chair of the global cross-functional Clinical Trial Team (CTT), develop agenda and run meetings.
• Key contributor to the Data Review Plan; manages data flow and data cleaning process.
• Key contributor to the TMF Plan.
• Manages study-specific vendors, as appropriate.
• Supports the Clinical Program Lead with the development, management and tracking of the trial level budget(s) including approving invoices, forecast, and annual budget reviews.
• Develops materials for 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).
• Responsible for the maintenance of the electronic Trial Master File (eTMF) throughout the trial, including oversight and participation of periodic reviews.
• Contributes to operational excellence through process improvement and knowledge sharing.
• Participates and responds to Quality Assurance and/or regulatory authority inspection audits, responsible for identifying and implementing corrective action and risk mitigation and always maintains inspection readiness.
• Ability to collaborate with other departments to meet study timelines and goals.
• May serve as line manager to one or more Clinical Trial Assistants. Provides guidance and mentorship to the Clinical Trial Manager and Clinical Trial Assistant.
• Supports departmental functions and attends departmental meetings.

Qualifications and Education Requirements

• BA/BS or equivalent degree in relevant discipline (scientific or health-related background is preferred).
• Minimum of 4-6 (CTL) and 7-10 years (Sr. CTL) of experience in clinical research with a sponsor company or CRO (oncology/hematology experience required).
• Advanced 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.
• Able to independently manage various activities associated with multiple clinical studies in accordance with designated project assignments.
• Excellent knowledge on ICH/GCP, FDA-CFR.
• Able to communicate effectively.

Base Salary range: $218,286-$250,000. Menarini Stemline offers generous compensation and benefits packages, including Short and Long-Term Incentive Programs, Fidelity 401(k) (with 6% 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.

Qualifications

Qualifications and Education Requirements

• BA/BS or equivalent degree in relevant discipline (scientific or health-related background is preferred).
• Minimum of 4-6 (CTL) and 7-10 years (Sr. CTL) of experience in clinical research with a sponsor company or CRO (oncology/hematology experience required).
• Advanced 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.
• Able to independently manage various activities associated with multiple clinical studies in accordance with designated project assignments.
• 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: $218,286-$250,000. Menarini Stemline offers generous compensation and benefits packages, including Short and Long-Term Incentive Programs, Fidelity 401(k) (with 6% 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.