Director, Patient Experience & Regulatory Engagement

AstraZeneca • Boston, MA

11d • Onsite

About The Position

The Patient Experience Team (PEX) 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 impro ve 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 lead s the synthesis and application of PED , including patient preference studies, lived experience data and, patient reported 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 .

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

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

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director