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About This Role:
The Country Clinical Site Lead (CCSL) is a strategic, externally facing role that provides critical local operational and scientific expertise to support global clinical development strategies. Acting as a key liaison between investigators, research sites, CROs, affiliate teams, and global study teams, the CCSL helps ensure the successful delivery of clinical trials while maintaining a strong focus on quality, patient safety, and operational excellence.
The CCSL brings valuable country-specific insights to global development programs, ensuring local opportunities and needs are incorporated into study planning and execution. The role also serves as an escalation point for site-related issues, including patient safety and data integrity concerns, and supports effective resolution through collaboration with internal stakeholders.
Working within Biogen's Internalized Flexible Model, the CCSL partners closely with Clinical Site Engagement and Clinical Monitoring Operations teams, including Clinical Monitoring Leads (CMLs), Site Managers, and FSP partners, to promote seamless collaboration and drive successful country-level study execution.
What You’ll Do:
Support and manage the internalized flexible model, including effective collaboration (and potential management) with Clinical Monitoring Leads (CMLs), CRAs, and properly support communication with FSP partners, and ensure clear ways of working at the country level. Additionally, support and collaborate with partners working under the FSO model.
Maintain up-to-date local knowledge of therapeutic areas researched by Biogen and clinical trial requirements.
Engage in operational and scientific discussions to provide country-level information on studies and programs.
Drive global operational strategy by delivering study information.
Manage investigator and site relationships to foster collaboration and satisfaction.
Lead local activities for country and site selection to incorporate feedback from local stakeholders.
Serve as the primary contact for strategic development and execution of sponsor oversight of CRO activities.
Oversee activities like Sponsor Oversight Visits, audits, and inspections to ensure compliance with regulations.
Monitor trial progress, address local challenges, and align with global teams effectively.
Act as Lead CCSL for study or program leadership, including training and coordination of site selection activities.
Build relationships across the organization while operating remotely.
Who You Are: You are someone who thrives in an external-facing role, leveraging your deep clinical research experience and scientific knowledge to drive strategic decisions. Your organizational skills and project management abilities allow you to set clear goals and manage multiple tasks efficiently. You are customer-focused, culturally aware, and possess high emotional intelligence, which helps you build strong relationships and collaborate effectively. Your strong communication skills, including proficiency in English, enable you to assimilate new knowledge rapidly and convey complex information with clarity.
Required Skills:
Bachelors Degree with a science background and experience required; advanced/graduate degree preferred
8+ years of clinical research experience including experience managing clinical trial activities, especially sponsor oversight with CROs/vendors.
Understanding of cross-functional drug development processes and scientific/clinical knowledge across key therapeutic areas.
Familiarity with ICH/GCP and country regulations.
Strong organizational and project management skills.
Proficiency in relevant IT tools for virtual teamwork.
Excellent knowledge of clinical operational activities in local geography.
Strong communication skills, including English proficiency in non-English speaking countries.
Willingness to travel 50-75% (2-3x/month)
Preferred Skills:
Leadership skills and interpersonal skills.
Collaborative decision-making approach.
High emotional intelligence and cultural awareness.
Preferred Locations:
Colorado
Texas
Arizona
Midwest region
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
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 Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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