The Senior Manager of Early & Expanded Access Programs (EAP) will plan, design and execute EAP Programs according to the strategic objectives of the organization needs for each therapeutic area in collaboration with cross-functional teams. The individual will have accountability for the SOPs, process maps and associated team and vendor metrics, reporting & publishing.  

Additional Responsibilities Include:

• Execute EAP planning from start to completion, including procurement processes, slide-development, timelines, milestones, processes, budget and operations (SOPs/WIs, metrics) are published and maintained accordingly
• Prepare and implement strategies to monitor program performance and determine the need for operational and strategic improvements and document according to knowledge management principles
• Prepare strategic presentations and apply change, risk and resource management principles when needed to EAP programs. Ensure appropriate vendor management utilization, tracking and reporting.
• Ensure all appropriate processes and procedures are followed and thorough audit readiness, remediation and close out on any CAPAs documented accordingly.
• Ensure program operations and activities adhere to legal guidelines and internal policies
• Keep senior management informed with detailed and accurate reports or presentations
• Manages professional employees, supervisors or lower level managers; has accountability for the budget, performance and results of teams
• Addresses issues with impact beyond own team based on knowledge of related disciplines
• Applies best practices and knowledge of internal/external business challenges to improve products, processes or service

Key Words: Expanded Access, Early Access Care, Compassionate Use, CUP, Named Patient Supply, Investigational Drug, Pre-Approval Access, Project Management, Clinical Trials, Clinical Research, CRA, Managed Access Program, Medical Oversight, Protocol Writing,  Early Access to Medicine, Program Manager, MAPS, IND, Investigational New Drugs, IMP, Medical Affairs, EAP

• REQUIRES a Bachelor's Degree (Masters preferred) and 6-10 years of related professional experience working with Early and Expanded Access Programs (EAPs). Additional experience in a CRO or with an established EAP vendor is a plus.
• Strategic mindset as well as be able to lead and develop, without direct authority, a cross-functional group of internal and external stakeholders.
• Thorough understanding of project/program management techniques and methods
• Outstanding knowledge of data analysis, reporting and budgeting
• Team player with excellent communication and organizational skills
• Excellence in process work, document review, audit remediation
• Working knowledge of MS office and program management software (e.g. Basecamp, MS Project etc.)

Biogen is hiring a Senior Manager, Early & Expanded Access Programs (EAP) to execute a wide range of EAP programs as part of Biogen's 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. The candidate will be responsible for the critical delivery and reporting of overall success of each program in accordance with Biogen's policies, SOPs and regulations.