Global Safety Medical Director - Hematology/Oncology

Role Summary

Global Safety Medical Director - Hematology/Oncology. In this role you will be accountable for staff management and resource allocations in Global Patient Safety and support Global Patient Safety in establishing a highly effective global safety organization in full compliance with worldwide regulations. The Global Safety Organization is responsible for the overall safety profile and all product-related decisions and results for assigned products supporting the Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team and Global Safety Team and is a core member of the Executive Safety Committee. The GSO may also be assigned as a delegate for the TAH as needed.

Responsibilities

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness

Qualifications

• Required: MD or DO degree from an accredited medical school
• Required: Completion of an accredited medical or surgical residency
• Required: Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Preferred: Product safety in the bio/pharmaceutical industry or regulatory agency
• Preferred: Previous management and/or mentoring experience
• Preferred: Experience in the study/research and/or treatment of Oncology disease states