Associate Director, Cell Therapy Senior Patient Safety Scientist - Oncology

AstraZeneca

Gaithersburg, MD, USA
$126,991.20 - $190,486.80 usd annual; bonus/equity...
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Cell therapy safety science
Oncology/haemato-oncology therapeutic area
Safety documentation and reporting
** AstraZeneca is seeking an Associate Director, Cell Therapy Senior Patient Safety Scientist in Gaithersburg, MD, to oversee safety programs for oncology cell therapies. The role demands extensive experience in drug safety and risk management, focusing on creating and implementing safety strategies for clinical studies while collaborating across various teams. **

Job Summary

  • This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs, spanning the entire life cycle of cell therapy development and peri-/post-submission.
  • You will play a leading role in delivering the clinical safety strategy for your assigned cell therapy study/project(s).
  • Our strategy and ability to transform our medicines portfolio means we have a CGT drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines for oncology patients.

Matching Summary

Match Score: 75

** AstraZeneca is seeking an Associate Director, Cell Therapy Senior Patient Safety Scientist in Gaithersburg, MD, to oversee safety programs for oncology cell therapies. The role demands extensive experience in drug safety and risk management, focusing on creating and implementing safety strategies for clinical studies while collaborating across various teams. **

Salary

$126,991.20 - $190,486.80 USD Annual; Bonus/Equity: Short-term incentive bonus and long-term incentive program; Benefits: 401(k), paid vacation, holidays, leaves, health benefits

Skills & Requirements

Must-have

  • Cell therapy safety science
  • Oncology/Haemato-oncology therapeutic area
  • Safety documentation and reporting
  • Signal evaluation and risk mitigation
  • Cross-functional collaboration
  • US, EU, and UK PV regulations

Nice-to-have

  • AI tools for safety analysis
  • Global PV regulations
  • Mentoring junior colleagues
  • Transformative CGT development

Key Requirements

  • 5+ years in drug safety and risk management
  • Experience in clinical drug development
  • Experience in Post-Marketing Surveillance
  • Experience in MAA/BLA submissions
  • Experience authoring Periodic Safety Reports
  • Experience authoring Risk Management Plans
  • Bachelor's degree in sciences/pharmacy/nursing or advanced degree

Work Rights

Not specified

Tailored Resume

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