Director, Patient Experience & Regulatory Engagement
$151,600–$227,700 year
On-siteBoston, Massachusetts, United States
Job Summary
Lead synthesis and application of patient preference studies and lived-experience data to integrate the patient perspective across the medical product lifecycle. Drive cross-functional strategy with Development and Regulatory teams to advance patient experience data into regulatory submissions and prepare for patient participation in key meetings. Translate regulatory landscape shifts to inform data generation strategies and access expectations for HTAs and payors while managing strategic vendor partnerships. Provide strategic leadership to diverse stakeholder groups to generate evidence shaping patient-informed risk/benefit narratives. Conduct this work in an office environment with limited domestic and international travel (20-30%) to meet key stakeholders.
Required Qualifications
- Bachelor's degree
- 10+ years of experience in the Biotech/Pharmaceutical Industry or equivalent
- 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 ability to use a computer
- The ability to engage in communications via phone, video, and electronic messaging
- The ability to engage in problem solving and non-linear thought, analysis, and dialogue
- The ability to collaborate with others
- The ability to maintain general availability during standard business hours
- Limited domestic and international travel (20-30%) with the ability to travel to meet with key stakeholders
Desired Qualifications
- degree in data science or management preferred
- 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
- 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.