Director, Clinical Science - Solid Tumor Oncology

0750 Stemline Therapeutics Inc; New York (NY); Sur place; USD 218 000 - 255 000; Plein temps

Résumé du poste

Menarini Stemline is seeking a Director/Senior Director Clinical Scientist to lead the Solid Tumor Clinical Development program in a global setting. You will contribute to the planning, execution, and interpretation of oncology studies, ensuring scientific integrity and timely data delivery.

The role requires an advanced degree, 5+ years in drug development, and proficiency with GCP/ICH and FDA regulations.

Qualifications

• 5+ years’ drug development experience as a clinical scientist or related role.
• Advanced degree (MS, PharmD, PhD) or equivalent experience.
• Experience in late phase solid tumor oncology.
• Proficient with MS Word/Excel/PowerPoint and EDC systems (Medidata RAVE).
• Knowledge of GCP, ICH Guidelines and FDA regulations.

Responsabilités

• Plan, execute, and report clinical trials, primarily in oncology.
• Contribute to study protocols, ICFs/amendments and regulatory submissions.
• Collaborate with external partners and cross-functional teams; manage study committees.
• Develop and present training materials for sites and CRAs; present data at meetings.
• Support trial operations, CRF design, and data collection in line with protocol.

Connaissances

Clinical data review

Cross-functional collaboration

GCP/ICH knowledge

ETZ availability

Formation

MS/PhD or equivalent

Outils

Medidata RAVE

Microsoft Office

Description du poste

Menarini Stemline is seeking a Director/Senior Director Clinical Scientist to lead the Solid Tumor Clinical Development program in a global setting. You will contribute to the planning, execution, and interpretation of oncology studies, ensuring scientific integrity and timely data delivery.

The role requires an advanced degree, 5+ years in drug development, and proficiency with GCP/ICH and FDA regulations.