Director, Clinical Scientist, Solid Tumor

MENARINI Group•New York, NY

1d•$218,000 - $255,000

About The Position

Menarini Stemline is seeking a Clinical Scientist at the Director/Senior Director level 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 across a clinical development program. The Clinical Scientist works in a matrix environment as part of cross-functional teams and may contribute to candidate development projects in early- and/or late-phase development. The role collaborates closely with Clinical Development Medical Directors to provide scientific expertise for the design and delivery of clinical studies and programs. The position focuses primarily on oncology clinical trials. It includes clinical data review and safety monitoring; development and review of study and regulatory documents; collaboration with internal teams, external partners, and study committees; preparation of training and scientific presentations; and trial operations support. The position is classified as a corporate office role. The posting notes that Stemline withholds New York state income taxes for all corporate office employees, including employees working remotely, under the New York state employer convenience rule. The role requires willingness to work US Eastern Time Zone hours.

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

Review, analyze, and interpret clinical and medical data and study results, ensuring accurate 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 perform manual coding of adverse events and concomitant medications as needed.
Ensure processes and procedures are in place for clinical safety monitoring and patient safety.
Keep the Medical Monitor informed of pertinent study information, including safety and efficacy data.
Contribute to authoring clinical study protocols, Informed Consent Forms, and 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.
Provide prompt, quality responses to IRBs/ERCs, IDMCs, and other relevant groups.
Collaborate and liaise with external partners, including Key Opinion Leaders, in settings such as individual 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 about study activities and data status.
Anticipate study-related activities and 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 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 in collaboration with Data Management/Programming, and potentially participate in User Acceptance Testing.
Lead or support trial-level activities for one or more trials, as appropriate and with necessary supervision.