Director, Senior Patient Safety Scientist

AstraZeneca plc; Gaithersburg (MD); Presencial; USD 203.000 - 305.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Safety leadership

Pharmacovigilance

Risk management

Regulatory affairs

Strategic planning

Cross-functional leadership

AI governance

English fluency

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

This Is What You Will Do

The Director, Cell Therapy Patient Safety Scientist is a senior scientific leader within the Cell Therapy Patient Safety Unit, Global Patient Safety (GPS). The role leads safety science strategy and delivery for multiple and/or complex cell therapy assets, working with the Global Safety Program Lead (GSPL), Patient Safety Physicians and cross-functional partners. The Director integrates clinical, nonclinical, epidemiologic and real-world evidence to shape safety profiles, guide benefit-risk decisions, support governance and regulatory interactions, and protect patients across the product lifecycle.

You will be responsible for

• Lead safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets; define and document appropriate MedDRA search strategies.
• Set the safety science strategy for multiple, complex or high-priority assets and translate emerging data into clear recommendations for governance and development teams.
• Lead proactive pharmacovigilance and risk-management planning, including Global Risk Management Plans, REMS, risk-minimization measures and benefit-risk assessments.
• Provide strategic leadership and oversight for aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS and ad hoc analyses.
• Lead safety content and strategy for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, Data Monitoring Committee materials and core data sheets.
• Lead safety contributions to major submissions and health-authority responses, including NDA/BLA and MAA packages, and represent Patient Safety in inspections and complex regulatory interactions.
• Chair or lead safety forums and cross-functional discussions, including SSaMT/Safety Surveillance Team activities and presentations to SIRC or other governance bodies.
• Serve as a senior Patient Safety representative on global program and cross-functional teams; influence development strategy through scientifically grounded, patient-focused recommendations.
• Lead or advise on safety provisions in third-party agreements and partnerships, ensuring scientific quality, clear accountabilities and regulatory compliance.
• Mentor safety scientists, build capability across the function and provide expert training in cell therapy safety, pharmacovigilance methods and benefit-risk assessment.
• Sponsor process improvements and functional standards for safety analytics, reporting, governance and regulatory readiness.
• Define and oversee responsible use of agentic AI in safety workflows, including use-case selection, human-in-the-loop controls, validation, traceability, data protection, output verification and benefit realization.
• Partner with digital, data science, clinical and regulatory colleagues to scale validated agentic AI solutions and establish fit-for-purpose governance and performance measures.
• Support additional Patient Safety priorities as directed by the line manager.

You will need to have

• Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline with substantial relevant experience, or an advanced degree with relevant experience.
• Extensive pharmaceutical, biotechnology or CRO experience in patient safety/pharmacovigilance and drug development, including leadership of complex safety or scientific activities.
• Proven experience setting program-level safety strategy and leading at least three of the following: early/late clinical development; NDA/BLA or MAA submissions; periodic safety reports; risk-management plans; signal management; governance interactions; health-authority responses.
• Strong knowledge of US, EU and UK pharmacovigilance regulations and ICH guidelines; ability to interpret evolving requirements and define an organizational response.
• Demonstrated leadership in benefit-risk assessment, scientific communication, matrix influence, decision-making under uncertainty and management of multiple priorities.
• Advanced scientific writing and presentation skills, with the ability to communicate complex safety issues to senior governance bodies and external stakeholders.
• Hands-on expertise designing or overseeing agentic AI workflows using large language models and related tools, with knowledge of responsible AI, human-in-the-loop oversight, validation, traceability, data privacy and regulated-quality expectations.
• Fluent written and verbal English.

We would prefer you to have

• MSc, PhD, PharmD or equivalent advanced degree in immunology, autoimmune disease, pharmacology, epidemiology or a related discipline.
• Expertise in cell therapy safety, including proactive identification, characterization, monitoring and mitigation of key cell therapy risks.
• Deep experience in immunology cell therapy development, peri-submission and/or post-marketing safety.
• Experience with pharmacoepidemiology, real-world evidence, quantitative safety methods or predictive safety analytics.
• Experience leading regulatory inspections or health-authority interactions and influencing senior governance decisions.
• Experience deploying governed agentic AI solutions in a GxP or similarly regulated environment, including evaluation frameworks, auditability and change control.
• Knowledge of pharmacovigilance regulations in China, Japan, Australia and other regions.

Working environment

The duties of this role are generally conducted in an office environment. Employees must be able, with or without reasonable accommodation, to use a computer; communicate by phone, video and electronic messaging; engage in analysis, problem-solving and dialogue; collaborate with others; and maintain general availability during standard business hours.

Why AstraZeneca?

At AstraZeneca, we work together to push the boundaries of science and deliver life-changing medicines. You will join an inclusive, collaborative environment that values integrity, continuous learning and diverse perspectives, with the opportunity to shape the future of cell therapy safety and responsible AI-enabled safety science.

So, what's next?

Are you ready to bring your safety-science expertise to our team? We look forward to hearing from you.

The annual base pay for this position ranges from $203K to $305K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

# Cell Therapy

Date Posted

09-Nov-2026

Closing Date

29-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.