Biogen Senior Manager, Expanded Access Programs (EAPs) in Cambridge, Massachusetts
A successful Senior Manager of Expanded Access Programs must have a deep knowledge of program management skills and process optimization principles. They must have a strategic mindset as well as be able to lead and develop without direct authority and be able to lead a cross-functional group of stakeholders. They should be proactive, work independently, with guidance in only the most complex situations. They will have accountability for the SOPs, process maps and associated team and vendor metrics, reporting & publishing. They need to have audit experience and remediation implementation. The candidate should be able to execute on business plans, contribute to the development of the team strategic initiatives. They will also need to be able to manage, problem solve and address issues with impact beyond the EAP team and utilize knowledge and expertise of related disciplines.
Additional Responsibilities Include:
Plan, design and execute Early Access Programs according to the strategic objectives of the organization needs for each therapeutic area in collaboration with cross-functional teams
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, remediations 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
Requires a Bachelor's Degree (Masters preferred) and 7-10 years of Early/Expanded Access Programs (EAPs) professional experience, CRO experience additionally is a plus
Experience leading within a matrix organization and appropriate multi-stakeholder management at different levels of seniority
Thorough understanding of project/program management techniques and methods
Excellent Knowledge of performance evaluation techniques and key metrics
Outstanding knowledge of data analysis, reporting and budgeting
Working knowledge of MS office and program management software (e.g. Basecamp, MS Project etc.)
A business acumen with a strategic ability
Excellent organizational, working in a team and leadership skills
An analytical mindset with great problem-solving abilities and flexibility in thought
Excellent communication skills
Excellence in process work, document review,
Experience in audit remediation,
Requires specialized depth and/or breadth of expertise in own job discipline or field
Biogen is looking for an experienced Senior Manager, Expanded Access Programs (EAPs) to execute a wide range of EAP programs as part of the Global EAP team. The candidate will be responsible for the delivery and reporting of overall success of each program. This role will be based in Cambridge, MA.