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The Associate Director of Early and Expanded Access Programs (EAP) willhave a deep knowledge of program management principles, vendor oversight and regulatory requirements. They must have a strategic mindset as well as be able to lead and develop without direct authority over a cross-functional group of stakeholders and will be accountable for the performance and results of multiple related teams, development of departmental plans, including business and/or organizational priorities. The goal is to ensure every program will be delivered successfully and add the highest possible value to patients and Biogen.
Additional Responsibilities Include:
Key words: Early Access Programs, Named Patient Programs, Expanded Access, Compassionate Use, CUP, Managed Access, MAPS, IND, Investigational New Drugs, IMP, Pre-Approval Access, Medical Affairs
Biogenlooking for anAssociate Director of Early & Expanded Access Programs (EAP) to lead a wide range of EAP programs globally, including the ALS and pipeline programs as part of the Global EAP team. Early and Expanded Access Programs offer ethical, compliant, and controlled mechanisms of access to investigational medicine outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. This individual is a key player in Medical Affairs andwill be accountable for the delivery and overall success of each EAP program globally and inform management on progress and performance.