About This Role

The Associate Clinical Country and Site Lead (aCCSL) will be strategically focused on providing key local operational and scientific expertise to drive country and regional level clinical development strategy, enable local partnerships that enhance customer satisfaction (Internal and external), and support focused delivery and execution of the R&D pipeline. 
 

The aCCSL (in close collaboration with their CCSL colleagues) 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 aCCSL role may be asked to provide operational direction and prioritize activities for local CCSA 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 oversight of CRO activities, with a country level focus on performance. The aCCSLs 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. 
 

What You’ll Do

• 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.
•  Manage investigator and site knowledge/relationships to inform teams of country level capabilities, interests, needs and satisfaction levels.  This would involve the development of a country level GCO investigator engagement strategy, or execution of global strategy (in collaboration with WM or local medical) to position Biogen as the company partner of choice for clinical trials.
•  Lead/support 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).
•  Primary country level GCO/Biogen contact for all GCO clinical studies, leading interactions or managing CCSA 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).
• Support local or regional projects or other CCSM activities as a representative of their country(ies).

Required Skills

• Science background and education (B.A or B.Sc)
• Extensive (min 5 years) experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors.
• Deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling CCSL to discuss compound, development plans, and protocol endpoints with investigator site personnel.
• Strong organizational skills and leadership skills, especially project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activities.
• Working knowledge of relevant IT tools to promote virtual team working.
• Excellent knowledge of clinical operational activities/challenges across local geography.
• Customer focused, with excellent leadership, interpersonal skills, cultural awareness, high emotional intelligence and collaborative decision-making approach. Must build relationships throughout and across the organization whilst operating remotely
• Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities
• Strong communication skills.
• Ability to assimilate new knowledge rapidly

As a condition of employment, Biogen Canada requires that all successful candidates provide proof of full COVID-19 vaccination status prior to their start date. 

We remain committed to an accessible, inclusive and barrier free workplace; written requests for an exemption will be considered on a case-by-case basis.
 

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.

This role will be a remote country/regionally aligned role, strategically focused on providing key local operational and scientific expertise to drive country and regional level clinical development strategy, enable local partnerships that enhance customer satisfaction (Internal and external), and support focused delivery and execution of the R&D pipeline