Clinical Country Lead

This is an office/ field based country/regionally aligned role, strategically focused on providing key local operational and scientific expertise to drive global clinical development strategy,  enable local partnerships that enhance global customer satisfaction (Internal and external), and support the country focused delivery and execution of the R&D pipeline. 

    
The CCL will provide global teams with detailed local operational and scientific knowledge that will inform the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully integrated into operational plans.

    
At the country level, the CCL role will provide operational direction and prioritize activities for CCA resources to provide a single point of contact for Investigators, affiliate office staff, CRO staff, and GCO/global teams to deliver local clinical trial quality and relationship oversight of CRO activities, while providing a country level focus on performance.

    
CCLs will also serve as a site escalation point for investigator concerns, including those related to data integrity or issues which are un-resolved by the CRO,  so that these may be communicated to the appropriate Biogen responsible party.  

 Maintain current awareness/information
pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial related needs of clinicians in community.  Hold specific operational and scientific discussions and act as local GCO expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy. Coordinate cross functional local affiliate input as required to provide appropriate country level input into Clinical Development Plan

Act as Lead CCL when appointed to this role. This role includes but is not limited to membership in CDT and SMT(s), coordinating Program and Study Country Foundation, investigator assessment of (and feedback on) programs and protocols, and Site Selection activities. Also responsible for training CCLs on therapeutic area and program, program and trial level communications, and ownership of CCM activities related to a given program or trial.

Primary country level GCO/Biogen contact for all GCO clinical studies, leading interactions or managing CCA interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO staff, and GCO/global teams.  Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones Primary country level GCO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities (e.g. SOV’s, audits, and inspection support) Lead and manage required local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders. (e.g. investigator assessment of (and feedback on) programs and protocols)

Science background and education (B.A or B.S; advanced degree preferred)

Extensive (7 + years) experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors.

high level knowledge of English.