Director, Patient Experience & Regulatory Engagement

This is what you will do: 

The Patient Experience Team (PEX) team fuels Alexion AstraZeneca Rare Disease’s corporate priorities by ensuring the patient voice guides every stage of our work.  

Increasingly global regulators, and decision makers such as HTA bodies and payors recognize the value of lived patient experience data (PED) to inform therapeutic development regulatory decision-making in line with guidance including patient-focused drug development, while supporting coverage and access decisions that can improve real-world outcomes. 

The Patient Experience and Regulatory Engagement role serves as a strategic bridge between Global Medical Affairs, R&D, Global Marketing & Market Access and the patient community. The role leads the synthesis and application of PED, including patient preference studies, livedexperience data, patientreported outcome measures to ensure the patient perspective is integrated across the medical product lifecycle.  The role provides strategic leadership for the incorporation of patient perspectives into regulatory interactions, including preparatory strategy for patient participation in key meetings where appropriate. 

You will be responsible for: 

• Leads cross functional strategy with Development and Regulatory teams to advance the integration of patient experience data into regulatory submissions. 

• Translating shifts and trends in the regulatory landscape that will inform patient experience data generation strategies and proper implementation including access expectations for HTAs and payor bodies 

•  Provides strategic leadership across cross-functional teams and patient community stakeholders to generate patient experience data (PED)—including patient preference, patient-generated, and lived-experience evidence ultimately shaping patient‑informed risk/benefit narratives to support external stakeholder interactions. 

• Lead strategic vendor partnerships on targeted initiatives, ensuring clear scope definition, effective stakeholder management, and timely delivery of highquality outputs. 

• Limited domestic and international travel (20-30%) with the ability to travel to meet with key stakeholders. 

You will need to have: 

• Bachelor’s degree: degree in data science or management preferred.  

• 10+ years of experience in the Biotech/Pharmaceutical Industry or equivalent; preference for experience in Regulatory, Clinical Development, or Consulting. 

• Experience developing innovative solutions and ability to adapt quickly to disease‑area and team needs. 

• Drive change by transforming traditional data‑use practices into leading‑edge, modern approaches working in partnership with colleagues. 

• Demonstrated passion for patient and caregiver focused work. 

• Demonstrated ability to influence senior leaders and drive strategic decisions across complex global matrix organizations 

• An understanding of patient-focused drug development, experience generating or synthesizing patient experience data as part of regulatory submissions 

•  Demonstrated willingness and ability to leverage artificial intelligence and other emerging technologies to enhance efficiency, insight generation, and decision-making. 

• Demonstrated ability to lead complex global initiatives, influence diverse stakeholder groups, and drive execution through matrix teams. 

• The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.  

We would prefer for you to have: 

• Advanced degree a plus (e.g., MPH, MBA, MPA,PhD. MD etc.)  

• Experience or previous engagement working for or with regulatory authorities and/or payor bodies 

• Experience in Rare Disease 

• Knowledge of regulatory authorities in multiple countries 

• Proficiency in one or more languages in addition to English 

The annual base pay for this position ranges from $151,600- $227 -700. 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 experience. In 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.