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Senior Director, Product Safety – Cellular Therapy, Hematology
Johnson & JohnsonProduct Safety Head responsible for safety oversight and strategic direction of cellular therapy products. Leading risk management activities in hematology with interdisciplinary collaboration.
About the role
Key responsibilities & impact- Shape the safety strategy and risk management for all the products within the assigned product during drug development and post-marketing
- Partner closely and effectively with the TASH, Head of Global Safety Strategy and Risk Minimization (GSSRM), Chief Safety Officer (CSO), Chief Medical Officer (CMO) JJ IM, Qualified Person for Pharmacovigilance (QPPV) JJ IM, other JJ IM R&D leaders
- Provide oversight, medical expertise and leadership to the product Medical Safety Officers (MSO)
- Provide input into key regulatory documents
- Ensure consistency of medical safety-related processes
- Serve as the Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee
- Support TASH and GSSRM Head in proactively managing the annual budget and planned resource allocation
- Act ethically and responsibly to ensure patient safety is paramount
- Ensure compliance of drug safety activities and processes with global legislation and regulatory requirements
Requirements
What you’ll need- Medical Degree or equivalent
- Physician (MD or equivalent) with 8 or more years of substantial Pharmaceutical Industry experience; clinical experience highly preferred
- Significant skills in clinical medicine and pharmacovigilance, including experience in post-marketing safety assessment
- Knowledge of cellular therapy products and the associated PV guidelines and global regulatory framework
- Demonstrated in-depth knowledge of principles of cellular therapy product development, pharmacology, clinical trial methodology and design
- Proven track record in dealing with difficult safety issues, clinical safety data, interactions with domestic and international regulatory departments / agencies
- Excellent verbal and written communication skills, including formal presentation skills
- Fluency in written and spoken English.
Benefits
Comp & perks- Inclusive work environment
- Diversity, equity, and inclusion initiatives
ATS Keywords
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Hard Skills & Tools
medical degreeclinical medicinepharmacovigilancepost-marketing safety assessmentcellular therapy productsclinical trial methodologyclinical trial designsafety data analysisregulatory compliancedrug safety activities
Soft Skills
leadershipcommunication skillspresentation skillsethical decision-makingcollaborationoversightresource allocationproblem-solvinginterpersonal skillsstrategic thinking