New · posted Nov 10
AstraZeneca · Biotechnology
Director, Senior Patient Safety Scientist
- Gaithersburg, MD
- On-site
- Full-time
- Director
The role
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.
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.
What you need
Skills named in this posting
What you'll do
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.
Pay and benefits
$203,000 – $305,000 a year
Employer providedSo, 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.
Qualified retirement programs
Paid time off
Health coverage
Dental coverage
Vision coverage
Short-term incentive bonuses and equity-based awards
Where you'll work
Gaithersburg, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Gaithersburg, MD
From the posting
About AstraZeneca
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.
Equal opportunity, accessibility and legal noticesAstraZeneca's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Director roles in the US82 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $203,000 | — | $305,000 |
| All US (middle half) | $223,125 | $258,250 | $278,500 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 157 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- GMP and compliance6
- Documentation and SOPs5
- Quality systems and risk5
- Validation and qualification4
- Regulatory submissions3
- Clinical trial conduct3
- Lab testing and methods2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Safety & Pharmacovigilance work in biotechnology, led by the four this posting names, each linked to the agency or standards body that publishes it.
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical historyNamed in the posting
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concernsNamed in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 44
- Open roles
- 44
- Distinct roles
- 10
- Locations
By discipline
- Clinical18 41%
- Quality14 32%
- Regulatory12 27%
By level
- Director28 64%
- Associate & Specialist12 27%
- Senior & Principal2 5%
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Director, Senior Patient Safety Scientist at AstraZeneca
Applications close November 30. $203K–$305K a year, employer provided.