About This Role

This role is a member of the leadership team for Global Clinical Operations representing the site engagement for the US region, which encompasses all sub-regions of the US and Puerto Rico and represents the largest region by clinical trial volume (>900 sites, >45 studies) for the Biogen portfolio. The CCSM Regional Head provides guidance, leadership and direction through a management team of Associate Directors and Senior Managers, and is accountable for the performance of the CCSM function in the US for all Biogen clinical trials across all phases of development and all therapeutic areas. Additionally, the CCSM Regional Head partners closely with the GCO Patient Engagement and Health Equity teams to ensure health equity and under-represented patient population goals are met in the region, which includes developing new partnerships with investigative sites in new geographies (incl metro areas).  The CCSM Regional Head for US also partners closely with the US Regional President and US regional leadership team (led by the Biogen Regional President), ensuring Biogen’s US regional business needs are appropriately reflected in country selection strategy for clinical trials in the pipeline and applies commercial awareness to develop operating plans and drive performance of GCO in the US region.  The CCSM Regional Head is the primary stakeholder accountable for engagement with senior regional stakeholders, including WW Medical regional leads and other regional and global commercial stakeholders.   The CCSM Regional Head drives the overarching regional strategy for the US region, as well as maintaining site intelligence information to help inform site selection activities and maintain site engagement information in a fit-for-purpose system. The CCSM Regional Head is accountable for resource (budget and headcount) management for the collective CCSM organization, development of their staff, and for leading an organization of continuous improvement.

What You’ll Do

• Strategic and operational management to support global program strategy development, country foundation deliverable, provision of regional strategy and site intelligence information to guide country and selection strategies, and clinical trial delivery in the region with operational excellence
• Provision of proactive clinical operational intelligence on the regulatory and clinical trial environment and highlight specific requirements at the local level
• Point of contact for site engagement and ensuring the voice of the site in program operational strategy development
• Point of contact for the Worldwide Medical function to inform about GCO country activities, establish regional strategies and provide contacts for issue escalation
• GCO senior leadership activities and decision-making forums
• Manage a team of ~19 FTEs (will expand with growth of portfolio and UP sites)

Who You Are

You are an experienced people manager with strong project management skills and experience leading internal and external global cross-functional projects.  You have strong interpersonal and communication skills and have a significant ability for strategic planning with the ability to influence.

Required Skills

• Bachelor’s Degree
• 15+ years’ experience in clinical development
• Experience across multiple clinical operations disciplines including field-based site-facing clinical operations roles, clinical trial delivery via an outsourcing model
• Strong understanding of regulatory environment regarding GCP, clinical trial regulations and regulatory guidances pertinent to clinical trial conduct in assigned region

Preferred Skills

• Advanced/Graduate Degree
• R&D project leadership experience

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.