Associate Director, Patient Safety Scientist – Cell Therapy (Immunology)
Location: Gaithersburg, Maryland, United States
Job ID: R-238131
Date Posted: 27–28 Oct 2025
Closing Date: 17 Nov 2025
🔷 Role Overview
AstraZeneca is seeking an experienced Associate Director, Patient Safety (PS) Scientist to support safety strategy, safety surveillance, and risk management for cell therapy programs in the Immunology Therapeutic Area.
You will collaborate with Safety Physicians, other PS Scientists, Clinical Project Teams, and cross-functional partners to:
Analyze and interpret safety data from clinical trials & marketed products.
Author safety documents and regulatory reports.
Lead safety-related meetings and provide strategic safety input.
Contribute to shaping the safety profile of cutting-edge cell therapy assets.
You will report to the Cell Therapy Immunology Global Safety Project Lead (GSPL).
🔷 Key Responsibilities
1. Pharmacovigilance Leadership
Lead proactive PV activities and risk management planning for cell therapies.
Prepare the safety components of:
Global Risk Management Plans (RMPs)
Risk Evaluation & Mitigation Strategies (REMS)
Direct PS activities in cross-functional project teams for development and marketed products.
2. Safety Document Ownership
Lead and provide safety expertise for:
Investigator Brochures
Protocols
Informed Consent Forms
Clinical Study Reports
Author or provide strategic oversight of periodic regulatory documents:
DSURs, PSURs, PBRERs
Drive authorship of the Reference Safety Information (RSI).
3. Safety Data Analysis & Communication
Present complex issues to the Safety Information Review Committee (SIRC).
Evaluate data and discuss findings with SIRC Chair, GSPL, and key stakeholders.
Lead safety contributions to:
NDA/BLA submissions
MAA submissions
Health authority responses
4. Cross-Functional & External Collaboration
Work collaboratively with teams across:
Global Regulatory Affairs, Clinical, Commercial, and PV teams.
Participate in contract negotiations regarding safety components.
5. Leadership & Mentoring
Train and mentor junior PV scientists in safety processes and analytical methods.
Support high-quality delivery of the Safety Strategy & Management Team (SSaMT) and Safety Surveillance Team.
🔷 Essential Requirements
Education
Bachelor’s degree in sciences/pharmacy/nursing with relevant experience, OR
Advanced degree (MSc/PharmD/PhD) with relevant experience.
Experience & Skills
Experience in at least 3 of the following areas:
Early/late-phase clinical drug development safety strategy
MAA/BLA submission strategy & safety authoring
Periodic Safety Reports (PSURs/PBRERs/DSURs)
Global Risk Management Plans
Governance board interactions
Strong knowledge of US/EU/UK PV regulations & ICH guidelines
Other required skills:
Ability to manage multiple projects and prioritize effectively
Strong performance in matrixed organizations
Fluent written & spoken English
🔷 Preferred Qualifications
MSc/PhD/PharmD in Immunology or Autoimmune Diseases
Experience in Cell & Gene Therapy (CGT) product development or safety monitoring
Knowledge of pharmacoepidemiology
Expertise using AI tools (ChatGPT, Claude, LLMs, Agentic AI)
Knowledge of PV regulations in China, Australia, Japan, and wider Asia
🔷 Compensation & Benefits
Base Salary Range: $126,991.20 – $190,486.80 (USD annually)
Overtime available for hourly/non-exempt roles
Additional benefits:
Short-term incentive bonus
Equity-based long-term incentive program (for salaried roles)
Retirement contribution (401k)
Paid vacation, holidays, and leaves
Health coverage (medical, dental, vision, prescription)
Employment is at-will. Salary may be modified based on individual or company performance & market factors.
🔷 Why AstraZeneca?
A Great Place to Work promoting innovation, integrity, and collaboration
Inclusive culture with strong focus on continuous learning, growth & development
Work on a transformative Cell & Gene Therapy (CGT) pipeline in oncology
Opportunity to influence safety strategy for cutting-edge therapeutics
🔷 What’s Next?
If you're imagining joining the team—AstraZeneca is ready to hear from you. Apply soon before the closing date.
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