Global Cell Therapy Safety Leader

Biopharma Careers; Gaithersburg (MD); On-site; USD 259,000 - 432,000; Full time

Job summary

AstraZeneca Gaithersburg is seeking a Global Safety Program Lead for Cell Therapy Oncology & Onco-Hematology. The role focuses on end-to-end safety strategy and cross-functional leadership across development and post-marketing.

In-person office presence is expected with flexibility for home-based work where feasible. The role requires a medical or scientific degree with deep pharmacovigilance experience and a proven track record in asset safety strategy, global regulations, and governance

Qualifications

• Medical degree or equivalent in biomedicine with extensive clinical safety/pharmacovigilance experience.
• Strong experience leading asset safety strategy and influencing clinical studies/programs.

Responsibilities

• Lead the Safety Strategy & Management Team for the asset, aligning safety goals with product strategy.
• Own safety content including safety TPP, Go/No-Go criteria, and toxicity management guidelines.
• Represent Global Patient Safety at governance forums and respond to complex safety issues.
• Ensure timely, compliant safety documents (RMPs, PSURs/PSRs) and contributions to regulatory submissions.
• Provide strategic safety leadership to safety medical directors and scientists across studies and programs.
• Build internal and external networks to drive cross-functional safety actions and due diligence support.
• Guide study design inputs with AI tools for safety signal monitoring and interpretation.
• Line-manage safety physicians/scientists and drive continuous improvement in safety processes.

Skills

Clinical safety

Leadership

PV Regulations

Regulatory submissions

Education

Medical degree

PhD

Job description

AstraZeneca Gaithersburg is seeking a Global Safety Program Lead for Cell Therapy Oncology & Onco-Hematology. The role focuses on end-to-end safety strategy and cross-functional leadership across development and post-marketing.

In-person office presence is expected with flexibility for home-based work where feasible. The role requires a medical or scientific degree with deep pharmacovigilance experience and a proven track record in asset safety strategy, global regulations, and governance