Director, Patient Experience & Regulatory Engagement

AstraZeneca•Boston, MA
•$151,600 - $227,700

About The Position

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 patient experience data (PED), including patient preference studies, lived experience data, and patient-reported outcome measures, to integrate the patient perspective across the medical product lifecycle. It provides strategic leadership for incorporating patient perspectives into regulatory interactions, including preparation for patient participation in key meetings where appropriate. The role advances Alexion AstraZeneca Rare Disease’s patient-focused corporate priorities by ensuring the patient voice guides its work. It supports the use of lived patient experience data in therapeutic development and regulatory decision-making, as well as coverage and access decisions intended to improve real-world outcomes. The position includes limited domestic and international travel (20–30%) to meet key stakeholders. Duties are generally conducted in an office environment, with availability during standard business hours.

Requirements

  • Bachelor’s degree.
  • 10+ years of experience in the biotech/pharmaceutical industry or equivalent.
  • Experience developing innovative solutions and adapting quickly to disease-area and team needs.
  • Ability to drive change by transforming traditional data-use practices into modern approaches in partnership with colleagues.
  • Demonstrated passion for patient- and caregiver-focused work.
  • Ability to influence senior leaders and drive strategic decisions across complex global matrix organizations.
  • Understanding of patient-focused drug development and experience generating or synthesizing patient experience data as part of regulatory submissions.
  • Willingness and ability to leverage artificial intelligence and other emerging technologies to enhance efficiency, insight generation, and decision-making.
  • Ability to lead complex global initiatives, influence diverse stakeholder groups, and drive execution through matrix teams.
  • Ability, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.

Nice To Haves

  • A degree in data science or management is preferred.
  • Experience in Regulatory, Clinical Development, or Consulting.
  • Advanced degree, such as MPH, MBA, MPA, PhD, or MD.
  • Experience or prior 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

  • Lead cross-functional strategy with Development and Regulatory teams to advance integration of patient experience data into regulatory submissions.
  • Translate changes and trends in the regulatory landscape into patient experience data generation strategies and appropriate implementation, including access expectations for HTAs and payor bodies.
  • Provide strategic leadership across cross-functional teams and patient community stakeholders to generate patient experience data, including patient preference, patient-generated, and lived-experience evidence, shaping patient-informed risk/benefit narratives for external stakeholder interactions.
  • Lead strategic vendor partnerships on targeted initiatives, defining scope, managing stakeholders, and delivering high-quality outputs on time.
  • Prepare strategy for patient participation in key regulatory meetings where appropriate.
  • Travel domestically and internationally, approximately 20–30%, to meet with key stakeholders.

Benefits

  • Short-term incentive bonus opportunity.
  • Eligibility to participate in an equity-based long-term incentive program for salaried roles.
  • Retirement contribution for hourly roles.
  • Commission payment eligibility for sales roles.
  • Qualified retirement program, including a 401(k) plan.
  • Paid vacation and holidays.
  • Paid leaves.
  • Health benefits, including medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.
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