Senior Manager, Medical Operations, Expanded Access Programs
Core
Operational management of Expanded Access Programs, individual patient expanded access, and post-trial access within Medical Affairs.
Role type
Senior Manager, Medical Operations
Builds
Managed access programs and drug supply logistics for pharmaceutical/biotech products
Domain
Pharmaceutical/Biotech, Clinical Research, Medical Operations
Deliverable
client delivery
Required skills
Program management, budget forecasting, vendor management, metrics analysis, systems management (SharePoint, QlikSense, Oracle, ESRA), process improvement, stakeholder alignment
Preferred skills
Advanced degree, experience in clinical research or medical operations, GCP, Investigator Initiated Studies, medical grants administration, registries, Compassionate Use/Managed Access programs
Technologies
SharePoint, QlikSense, QlikView, Oracle, ESRA portal
Responsibilities
Manage operational aspects of Expanded Access Programs and post-trial access, oversee program budgets and financial forecasting, manage drug supply for patient access programs, track project metrics and reporting timelines, manage vendors and financial tracking, ensure document archiving and audit readiness, align with alliance and internal stakeholders
Seniority
Senior, hands-on management with supervision
