Sr Director Product Safety Head - Cellular Therapy, Hematology
On-site · Raritan, New Jersey, United States or Horsham, Pennsylvania, United States
Job Summary
Senior Director, Product Safety Head responsible for safety oversight and strategic direction for cellular therapy products within hematology. Leads a team of Medical Safety Officers (MSOs) and end-to-end medical safety strategy across development and post-marketing, ensuring risk mitigation, regulatory submissions, and communication of safety concerns to senior management and health authorities. Builds consistent safety processes, drives risk minimization activities, and collaborates with Global Safety Strategy & Risk Minimization (GSSRM) and other GMS functions to optimize safety across multiple products. Oversees safety data assessment, aggregate reports, and regulatory interactions, including labeling committees and data review committees, while ensuring compliance with global regulations and promoting diversity and inclusion. Strong emphasis on leadership, strategic thinking, and cross-functional collaboration across Clinical TA, Medical Affairs, and Regulatory Affairs.
Required Qualifications
- Medical Degree or equivalent
- MD or equivalent required
- 8+ years of substantial Pharmaceutical Industry experience
- Management experience supervising a group of employees
- Knowledge of cellular therapy products and PV guidelines and global regulatory framework
- Experience in post-marketing safety assessment
- Ability to influence, negotiate and communicate with internal and external customers
- Experience presenting to technical and lay groups at public meetings (desirable)
- Fluent in English (written and spoken)
- Experience with regulatory filings (e.g., PSURs, REMS/RMPs) and pharmacovigilance
- Leadership and ability to manage cross-functional teams
- Ability to manage multiple critical issues and assess strategic data
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