Associate Director, Safety Epidemiology

At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledge-sharing ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams functions and even the globe.

Recognizing the importance of individualized flexibility our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind providing space where teams can come together to strategize brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people the planet and our business are interconnected which is why were taking bold action to address some of the biggest challenges of our time from climate change to access to healthcare and disease prevention.

AstraZenecasSafety Epidemiologyteam leads the strategy compose execution and delivery of postauthorisation safety studies (PASS) across a broad portfolio of marketed and pipeline medicines . We are also responsible and accountable for generating epidemiological insights to investigate safety signals that helps to advise regulatory decisionmaking benefitrisk assessment and risk management for AstraZeneca products across multiple therapy areas.

The Role

TheAssociate Director Safety Epidemiologyis a senior scientific role responsible for the endtoend delivery of sophisticated postauthorisation safety studies using realworld data. The candidate will collaborate across Global Patient Safety Regulatory Affairs Biostatistics Clinical and external partners to produce highquality decisionready evidence. The role also provides epidemiology strategy and input to key regulatory deliverables including Risk Management Plans safety signal evaluations and diversity plans to help ensure our medicines are safe and effective for all patients.

Key Responsibilities

• Lead study strategy and delivery: Advise the build protocol development analysis plan execution interpretation and reporting of PASS PMCs/PMRs and other pharmacovigilance studies using EHR/claims and other real-world data sources.

• Advance regulatory science: Develop explain and defend epidemiological approaches with health authorities (e.g. FDA EMA) and ensure regulatory commitments are met with rigor and on time.

• Characterise benefitrisk: Generate and synthesise epidemiological evidence to advise safety profiles support signal assessments and supply to qualitative and quantitative benefitrisk evaluations.

• Enable evidence diversity: Lead epidemiology strategies for FDA clinical trial diversity plans and conduct diversity focused real-world evidence analyses across race/ethnicity age and gender.

• Coordinate external collaborations: Select lead and mentor CROs and academic partners to ensure methodological quality visibility and reproducibility.

• Conduct literature syntheses: Plan and implement targeted and systematic literature reviews on safety topics and provide critical appraisal with clear recommendations.

• Influence cross functional strategy: Provide authoritative epidemiology input to Global Patient Safety and therapy area teams to advise development and lifecycle decisions.

• Uphold methods and standards: Champion guidelines in pharmacoepidemiology data quality causal inference confounding control and transparent reporting.

Impact of the Role

• Patient impact: Evidence produced directly supports regulatory actions and risk minimisation measures that protect patient safety globally.

• Scale and scope: Contributions span nearly 100 products across multiple therapy areas addressing sophisticated and novel safety questions.

• Methodological leadership: Application of sophisticated methods to complex realworld data to elevate how RWE advises pharmacovigilance and regulation.

• Stakeholder influence: Regular engagement with senior leaders and regulators; findings inform decisions of strategic importance.

Development Opportunities

• Scientific leadership: Build visibility as a subject matter expert in pharmacoepidemiology and RWE for safety.

• Portfolio breadth: Work across diverse therapy areas and data environments (EHR claims registries primary data collection).

• Mentorship and collaboration: Guide external partners and contribute to internal capability building; opportunities to mentor junior scientists.

• External engagement: Publish and present methods and findings; contribute to standards for PASS/RWE and diversity in evidence.

Essential Requirements

• PhD in pharmacoepidemiology epidemiology or a related health science field with substantial hands-on research experience.

• Demonstrated ability to apply sophisticated epidemiological methods to complex real-world safety questions.

• Proven experience conducting targeted and/or systematic literature reviews and providing critical appraisal of epidemiological studies.

• Strong collaborator with experience working across internal teams and with external partners (e.g. CROs academic groups).

• Excellent written and oral communication skills with the ability to translate complex methods and results into decision ready insights.

• Independent scientific leadership: Demonstrated ability to scope design and deliver end-to-end epidemiologic studies with limited supervision including setting breakthroughs managing risks and driving to decision ready outputs.

• Novel problem solving: Track record of addressing first-of-a-kind or poorly specified safety questions by formulating testable hypotheses selecting fitforpurpose methods and iterating solutions based on emerging evidence.

• Decision-making under uncertainty: Experience making timebound evidence based recommendations when data are incomplete or conflicting with clear articulation of assumptions limitations and risk tradeoffs.

• Methodological agility: Ability to adapt design and analytic strategies (e.g. target trial emulation advanced confounding control sensitivity/robustness analyses) to heterogeneous RWD and evolving regulatory expectations.

• Ownership and accountability: Consistent delivery against commitments; anticipates issues increases appropriately and implements corrective actions proactively.

Desirable Qualifications

• Doctoral research focused on medicines as the exposure of interest and/or safety outcomes.

• Experience delivering epidemiological studies in regulatory contexts (e.g. PASS PMCs/PMRs) and contributing to RMPs and signal management.

• Handson experience with secondary data (EHR/claims/registries) and primary data collection; familiarity with patient safety databases.

• Experience shaping study strategy and operations to deliver on time and to a high standard.

• Working knowledge of drug safety and medical terminology; experience summarising safety information in clinical or postmarketing settings.

• Experience contributing to benefitrisk assessments (qualitative and/or quantitative).

• Understanding of global safety regulations and RWE expectations from health authorities.

• Broad disease area knowledge and understanding of drug development and lifecycle management.

• Familiarity with the use of AI/ML tools to enhance day-to-day workflows and study delivery (e.g. protocol drafting support literature screening and evidence synthesis data quality checks and results communication)

Annual base salary for this position ranges from $ 135362.40 to $177663.15. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors including the candidates skills and experience job-related knowledge and other specific business and organizational some cases offers outside the range may also be considered to address unique circumstances.

In addition our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program 4 weeks paid vacation and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.

Ready to lead and encourage Apply now and take the first step towards an exciting career at Alexion AstraZeneca Rare Disease.

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.