Director, Cell Therapy Safety Science

AstraZeneca plc; Gaithersburg (MD); Vor Ort; USD 203.000 - 305.000; Vollzeit

Zusammenfassung

AstraZeneca plc in Gaithersburg, MD, seeks a Director, Cell Therapy Patient Safety Scientist, a senior leader within GPS. The role guides safety science strategy and delivery for complex cell therapy assets across governance bodies.

You will lead safety surveillance, risk management planning, and regulatory interactions while mentoring scientists and advancing agentic AI-enabled safety science. Strong leadership and English proficiency required.

Qualifikationen

• Bachelor’s degree in life sciences or related field with substantial experience.
• Extensive pharma/biotech patient safety/pharmacovigilance experience.
• Proven ability to lead complex safety strategies across assets.
• Strong knowledge of US/EU/UK pharmacovigilance regulations.
• Experience with agentic AI workflows in regulated environments.
• Excellent written and spoken English.

Aufgaben

• Lead safety surveillance, signal detection, and evaluation for cell therapy assets.
• Set safety science strategy for multiple high-priority assets.
• Lead pharmacovigilance planning, REMS, and risk-minimization.
• Provide oversight for DSURs, PSURs, PBRERs, and other safety reports.
• Contribute to regulatory submissions and health authority interactions.
• Mentor safety scientists and drive process improvements.

Kenntnisse

Safety leadership

Pharmacovigilance

Risk management

Regulatory affairs

Strategic planning

Cross-functional leadership

AI governance

English fluency

Ausbildung

Bachelor's degree

Advanced degree

Jobbeschreibung

AstraZeneca plc in Gaithersburg, MD, seeks a Director, Cell Therapy Patient Safety Scientist, a senior leader within GPS. The role guides safety science strategy and delivery for complex cell therapy assets across governance bodies.

You will lead safety surveillance, risk management planning, and regulatory interactions while mentoring scientists and advancing agentic AI-enabled safety science. Strong leadership and English proficiency required.