Senior Director, Clinical Scientist — Solid Tumor Oncology

Menarini Stemline; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Menarini Stemline is seeking a Director/Senior Director Clinical Scientist to join our Solid Tumor Clinical Development team. The role contributes to the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity of study data.

Domestic and international travel is required (5–10%). The role collaborates with Medical Directors and cross-functional teams to design and deliver clinical programs in oncology, and to prepare regulatory submissions and study

Qualifications

• 5+ years’ experience in drug development as a clinical scientist or related role.
• Advanced degree (e.g., MS, PharmD, PhD) required.
• Experience in late phase solid tumor oncology.
• Proficient with MS Office, EDC systems, and data review tools.
• Knowledge of GCP, ICH Guidelines and US FDA regulations.
• Willingness to work Eastern Time Zone hours.

Responsibilities

• Lead and perform clinical data review, analysis, and interpretation of study results.
• Design data review plans and monitor safety and efficacy trends.
• Draft study protocols, ICFs/amendments, and regulatory documents.
• Prepare TMF submissions and responses to IRBs/IDMCs.
• Deliver training materials for sites and CRA teams.
• Present study results at meetings and conferences.
• Support CRF design and UAT as needed.

Skills

Clinical development

Late-phase oncology

Cross-functional collaboration

Data review & safety

Regulatory submission knowledge

Education

Advanced degree (MS, PharmD, PhD)

Tools

Medidata RAVE

Job description

Menarini Stemline is seeking a Director/Senior Director Clinical Scientist to join our Solid Tumor Clinical Development team. The role contributes to the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity of study data.

Domestic and international travel is required (5–10%). The role collaborates with Medical Directors and cross-functional teams to design and deliver clinical programs in oncology, and to prepare regulatory submissions and study