Associate Director, Cell Therapy Senior Patient Safety Scientist Oncology

At AstraZenecawe work togetherto deliver innovative medicines to patientsacross global boundaries. Wemake an impact and findsolutionsto do this with integrity even in the most difficult situationsbecause we are committed to doing the right thing.

This isanopportunity tofurther develop yourpharmacovigilance (PV)experienceinsafety programsspanningthe entire life cycle of cell therapy developmentandperi-/ Scientists and Physiciansplay astrategicrolein developing our medicinesand thesafetyscienceof oncology Cell and Gene Therapy (CGT) pipelinewhich includesnovel technologies and combinationsprovides anintellectual challenge to the safety teams requiringabroad portfolioand scientificmanagement approach to develops as our portfoliodoes.

We are looking for an experiencedAssociate Director Senior Patient Safety (PS) Scientistto join our Patient Safety department workingin the Cell Therapy Oncology/Haemato-oncology Therapeutic this exciting and challenging role you will work collaboratively with the Global Safety Program Lead (GSPL) Safety Physician and other Patient Safety Scientists. You will contribute to training and coaching junior colleagues. You will contribute to high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s). You will playa leading role in delivering the clinical safetystrategy for your assigned cell therapy study/project(s). Yourability to work collaborativelywill facilitatecross-functional interactionswith colleagues from across AstraZeneca and externally including colleagues within Clinical Project Teams Global Regulatory Affairs and Global Commercial teams.

Asan Associate Director Senior Patient Safety Scientistyou will report to the Cell Therapy Oncology Global Safety Project Lead (GSPL). You willprovide leadership inaggregatingreviewinganalysingandinterpretingsafety-relateddatatogenerateinformationtosupportsafety decision-making by study/project teams as well as patients prescribers and payers with thegoalof will apply your strongPV oncology cell therapy scientificexperience knowledge and skillsto leadinall aspects ofsafetydocumentation including safety surveillance signal evaluation periodic report writingauthoring and/or providingstrategic safety reports andhealth authorityresponsesandthesafety content ofmarketing authorization applications.

Patient Safety sits within the Chief Medical Office where we have a crucial role to is an exciting period for us as well as for those poised to join strategy and ability to transform ourmedicinesportfolio means we have aCGT drug-developmentpipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines for oncology with complex disease challengeswe focuson exceptional performance to drive the best and most transformative CGT oncologydevelopmentprograms ever.

Essential Requirements

• A bachelors degree in sciences/pharmacy/nursing or related fieldwith relevant experience or an advanced degree with relevant experience
• At least 5 years experience in drug safety and risk management within the pharmaceutical biotech or CRO industry
• Patient Safety and/or Drug Developmentexperience working in or leading safety and/or scientific activities in at least 3 of the following areas:

• Clinical drug development in early and/or late phase: develop program level safety strategy including proactive risk identification and mitigation planning

• Post-Marketing Surveillanceincluding signal detection and evaluation

• MAA/BLA submissionssetting strategy; preparation and authoring of the safety related aspects of the Common Technical Document

• PeriodicSafetyReportsto establish and lead strategy preparation and authoring

• Risk Management Plans to establish and lead strategy preparation and authoring

• Governance board interactionsand communicationacross a range of activities

• Goodknowledge of PV regulationsin the US EU and UK as well as ICH guidelines

• Demonstrated ability to handle more than one project simultaneously prioritizing well and recognizing key issues

• Abilitytowork effectively in an advanced matrix structure

• Fluent in written and verbal English

Preferred Requirements

• MSc/PhD/PharmD in scientific discipline

• CGT product development and CGT safety monitoring experience

• Advanced understanding of pharmacoepidemiology

• Expertise in using AI tools (e.g. Chat-GPT Claude various Large Language Models (LLMs) Agentic AI)

• Goodknowledge of PV regulationsin China Australia Japan rest of Asia

Location:Gaithersburg MD USA

The annual base pay for this position ranges from $126991.20 USD Annual to $190486.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

So whats next

Are you already imagining yourself joining our team Good because we cant wait to hear from you.