Safety Strategy Lead, Immunology Cell Therapy

AstraZeneca; Gaithersburg (MD); Hybrid; USD 288,000 - 432,000; Full time

Job summary

AstraZeneca is seeking a Senior Medical Director, Global Safety Program Lead, Cell Therapy - Immunology to provide medico-scientific leadership for safety across development and postmarketing. You will shape safety strategy, lead safety physicians and scientists, and collaborate with Clinical Development, Regulatory, and Medical Affairs to drive informed decisions.

You will oversee safety contributions to regulatory submissions, plus governance forums, and build a culture of scientific rigor

Qualifications

• Medical degree or equivalent medical qualification.
• Extensive experience in clinical safety/pharmacovigilance and drug development across pharma/biotech or regulatory environments.
• Demonstrated cell therapy experience with involvement in clinical development and safety evaluation.
• Clinical or drug development experience in immunology, rheumatology, neurology, autoimmune disease, transplantation, or related fields.

Responsibilities

• Own end-to-end safety strategy, delivery, and oversight for assigned immunology cell therapy assets across development stages.
• Lead safety strategy and management teams with clear safety objectives.
• Own scientific/clinical safety content including TPPl safety Go/No-Go criteria and risk minimization.
• Provide safety input to study concepts, protocols, dose-escalation/expansion decisions, and data interpretation.
• Lead proactive identification and management of acute and delayed cell therapy risks (toxicities, infections, etc.).
• Represent Global Patient Safety at governance and external forums; align safety positions for key decisions.

Skills

Clinical safety

Pharmacovigilance

Drug development

Cell therapy experience

Immunology

Leadership

Communication skills

Education

Medical degree or equivalent

PhD or advanced degree

Job description

AstraZeneca is seeking a Senior Medical Director, Global Safety Program Lead, Cell Therapy - Immunology to provide medico-scientific leadership for safety across development and postmarketing. You will shape safety strategy, lead safety physicians and scientists, and collaborate with Clinical Development, Regulatory, and Medical Affairs to drive informed decisions.

You will oversee safety contributions to regulatory submissions, plus governance forums, and build a culture of scientific rigor