Associate Director or Director, Clinical Scientist, Solid Tumor

MENARINI Group•New York, NY

1d•$173,121 - $255,000

About The Position

Menarini Stemline is seeking an Associate Director or Director-level Clinical Scientist to join its Solid Tumor Clinical Development department. The role contributes to or leads the development, evaluation, planning, and execution of clinical studies, while ensuring scientific integrity and interpretation of study data for a clinical development program. The Clinical Scientist works in a matrix environment as part of a cross-functional team and may contribute to candidate development projects in early- or late-phase development. The role collaborates closely with Clinical Development Medical Directors to provide scientific expertise for designing and delivering clinical studies and programs. The position focuses primarily on oncology clinical trials and encompasses clinical data review and safety monitoring, clinical and regulatory document development, collaboration with internal and external stakeholders, training and scientific presentations, and trial operations support. The role may lead or support trial-level activities for one or more trials, with appropriate supervision. This is classified as a corporate office position. Under New York's employer convenience rule, New York state income taxes will be withheld for all corporate office employees, whether they work in New York or remotely. The position requires willingness to work US Eastern Time Zone hours. The stated base salary range is $173,121–$255,000. Menarini Stemline describes its workplace as inclusive and says reasonable accommodations may be made for qualified individuals with disabilities.

Requirements

At least 5 years of experience in drug development as a clinical scientist or in a related role in the pharmaceutical or biotechnology industry.
An advanced degree (e.g., MS, PharmD, or PhD) or equivalent experience.
Experience in late-phase solid tumor oncology.
Proficiency with Microsoft Word, Excel, and PowerPoint; EDC systems such as Medidata RAVE; and data review tools such as patient profiles and report-generating tools.
Knowledge of GCP, ICH Guidelines, and current US FDA regulations.
Willingness to work US Eastern Time Zone hours.

Responsibilities

Perform clinical and medical data review, analysis, and interpretation of study results, ensuring accurate data reporting.
Monitor emerging clinical data related to safety, efficacy, and PK/PD to identify study issues.
Design and execute clinical data review plans with cross-functional teams, evaluate data trends, and manually code adverse events and concomitant medications as needed.
Ensure processes and procedures are in place for clinical safety monitoring and patient safety.
Work closely with the Medical Monitor and keep them informed of pertinent study information, including safety and efficacy data.
Contribute to authoring clinical study protocols and Informed Consent Forms (ICFs) and their amendments.
Review and draft study and regulatory documents, including Briefing Books, Investigator Brochures, Clinical Study Reports, and clinical sections of regulatory submissions such as INDs and annual reports.
Maintain appropriate clinical documentation and submit clinical documents to the Trial Master File.
Ensure prompt, quality responses to IRBs/ERCs, IDMCs, and other relevant bodies.
Collaborate and liaise with external partners, including Key Opinion Leaders, in settings such as one-to-one meetings and investigator meetings.
Work with the Medical Director to establish and oversee study committees, such as Steering Committees and IDMCs.
Serve as the Clinical Science Representative on assigned cross-functional teams.
Provide management with regular, timely updates on study activities and data status.
Anticipate study-related activities or barriers and present potential resolutions to leadership.
Develop and present site and CRA training materials at Site Initiation Visits and Investigator Meetings.
Develop presentations and communicate study data results internally and externally to investigators and at scientific conferences and symposia, including through abstracts, posters, and publications.
Conduct literature reviews to interpret study data, inform next steps, and maintain current knowledge of the external scientific environment.
Ensure Case Report Form design supports protocol-aligned data collection, collaborating with Data Management/Programming and potentially participating in User Acceptance Testing.
Lead or support trial-level activities for one or more trials with necessary supervision.