Director, Patient Experience & Regulatory Engagement
Core
Strategic leadership integrating patient experience data (PED) and patient perspectives into regulatory submissions and interactions with global regulators, HTA bodies, and payors to support therapeutic development and access decisions.
Role type
Director, Patient Experience & Regulatory Engagement
Builds
Patient-informed risk/benefit narratives and regulatory strategies for rare disease therapeutics
Domain
Biopharmaceuticals / Rare Diseases / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, cross-functional collaboration, regulatory landscape analysis, patient experience data synthesis, stakeholder management, vendor partnership management, change management, global matrix organization navigation, AI/emerging technology adoption
Preferred skills
Advanced degree (MPH, MBA, MPA, PhD, MD), regulatory authority engagement, rare disease domain expertise, multi-country regulatory knowledge, multilingual proficiency
Technologies
Artificial intelligence, patient-reported outcome measures (PROMs), patient preference studies tools
Responsibilities
Lead cross-functional strategy to integrate patient experience data into regulatory submissions; Translate regulatory landscape shifts into patient experience data generation strategies; Provide strategic leadership to generate patient experience evidence shaping risk/benefit narratives; Lead strategic vendor partnerships for targeted initiatives
Seniority
Director, strategic leadership & cross-functional influence
