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Location

São Paulo, SP | Brazil

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Job description

 

Job Description

As our Clinical Country & Site Lead (CCSL)  you will be 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 focused delivery and execution of the R&D pipeline. 

At the country level, you will provide operational direction and prioritize activities 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 focus on performance. You'll 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.

Key Responsibilities:

• 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;
• Provide and manage investigator and site knowledge/relationships to highlight country level capabilities, interests, needs and satisfaction levels;
• Responsible for training CCSLs on therapeutic area and program, program and trial level communications, and ownership of CCSM activities related to a given program or trial;

Qualifications

• Science background and education (B.A or B.S; advanced degree preferred);
• Fluent Portuguese and English;
• Strong background on clinical research/studies (phase 2 and 3 are mandatory) in multinacional pharma companies or CROs;
• Strong experience on the Brazilian regulatory environment;
• At least 7 years of experience managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors.

Additional Information

• Hybrid model (at least 2 times a week in the office is required);
• There is no direct team;
• Reports to Sr Clinical Country and Site Lead;

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.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts

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Job tags

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Salary