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Biogen Associate Director, Early Access / Expanded Access (EAP) in Cambridge, Massachusetts

The Associate Director of Early and Expanded Access Programs (EAP) will have 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:

  • Initiate and set goals for the ALS & pipeline Early Access Programs according to the strategic objectives of the organization together with the PDC and regional teams. Manage ALS & Pipeline cross-functional working groups and associated communications globally

  • Oversee the ALS & Pipeline EAP from start to completion involving deadlines, milestones, processes, budget and operations and lead the launch excellence globally

  • Devise evaluation strategies, metrics and KPIs to monitor performance of the ALS & Pipeline EAP program and determine the need for strategic continuous improvements with vendor for the ALS & Pipeline EAP

  • People and professional management of contractors, including on-boarding & performance

  • Ensure all ALS & Pipeline EAP operations and processes are aligned with GXP SOPs and minimum standards, including quality management of all vendors. Make sure appropriate processes and procedures are implemented by the vendor and documented accordingly

  • Recognize new process launch needs and implement new processes, recognize and manage change and improvement needs, risk management and control – including SOP and policy creation/amendments

  • Ensure all ALS & Pipeline program operations and activities adhere to legal guidelines and internal policies

  • Oversee and control AOP, resource needs, budget planning, management and execution

  • Ensure appropriate levels of World Wide Medical (WWM) and organization-wide EAP trainings and associated material on CU/EAP are delivered and satisfactorily achieved as well as maintained

  • Keep senior management informed with detailed and accurate reports or presentations on all EAP business updates and strategic initiatives

  • Develop innovation mind-set within the EAP team and see efficiencies in daily operations and leadership in planning, executing and maintaining the ALS & Pipeline EAP Programs

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

  • Requires a Bachelor's degree (Masters/MBA is preferred) and 10+ years’ of relevant industry experience

  • Proven Early/Expanded Access Program experience is REQUIRED, CRO experience 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

  • Requires specialized knowledge and expertise in their own job discipline and deep experience in integrating related disciplinary knowledge

  • Provides leadership to managers and professional staff; develops departmental plans, including business, production and/or organizational priorities

  • May act as advisor to management and stakeholders. Identifies applications of functional knowledge to lead others to solve complex problem

  • Ability to apply knowledge of key business drivers and the factors that maximize department/area performance; interprets business challenges and recommends best practices to improve products, processes or services

  • Background in identifying and solving complex, operational and organizational problems leveraging the appropriate resources within or outside the department; ability to lead others to do the same

  • Skilled in persuading managers and leaders to take action and/or negotiates with external partners/vendors/customers

Biogen looking for an Associate 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 and will be accountable for the delivery and overall success of each EAP program globally and inform management on progress and performance.