About This Role

At Biogen Digital Health (BDH), we aspire to transform Biogen and patients’ lives by making personalized & digital medicine in neuroscience a reality. Powered by data-science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. Our team strives for real impact through excellence, innovation, and collaboration.

You will serve as Biogen’s Clinical Operations Lead (COL) responsible for leading clinical operations of an assigned Realworld Research Network in alignment with established procedures, SOPs, and applicable regulatory and industry standards to advance personalized medicine in the MS therapeutic area. Reporting to the Head Realworld Research Networks, you will ensure quality execution throughout the study lifecycle and partner with cross-functional teams to oversee all studies in support of the evidence generation strategy.  

What You’ll Do

• Develop and implement effective clinical study management strategies and tactics
• Leads and supports the onboarding, mentoring, and management (when appropriate) all RWRN site-facing team members to execute the site-level GxP oversight strategy including overseeing external contractors and Functional Service Provider (FSP) resources and providing input on resourcing strategy in support of the Head, Realworld Research Networks
• Chairs Study Management Team (SMT) meetings covering all studies, sub-studies and pilots and drives effective study team operations through clear communication and collaboration with cross-functional partners
• Proactively identifies risks or issues and escalates to senior leadership, when appropriate
• Responsible for the creation and maintenance of operational and quality oversight documents (e.g., monitoring plan) to ensure data quality and compliance with any applicable regulatory or industry standards (e.g., GCP)
• Proactively liaises with other clinical operations groups within Biogen and BDH to ensure alignment of study management approach
• Oversees study vendors, when applicable 

Who You Are

You combine strategic thinking and scientific rigor with exceptional execution, and you strive for excellence in all that you do. You are passionately committed to making a difference in patients’ lives, and you foster a culture of trust and empowerment that encourages openness, ideation, failing forward, and experimentation. You think big, start small, scale fast, and you know that magic happens through diversity of thought, expertise, culture, and background.

Required Skills

• BA or BSc; advanced degree preferred   A minimum of 2 years of clinical research / project management experience preferably with a sponsor managing clinical trials within quality, timeline, and budget expectations
• Prior investigator site and/or monitoring experience
• Excellent communication skills and team leadership experience
• Strong working understanding of cross-functional clinical development within Phase IV and realworld research

Why Biogen Digital Health?

You will join an international, diverse team of 100+ talented humans who are passionate about making our vision a reality. Our team at Biogen Digital Health rejects the status quo and lives by agile principles. You’ll work directly with an outstanding team of neuroscientists, clinicians, data scientists, biostatisticians, digital product managers, user experience designers, and engineers that work across disciplines to make a lasting impact for patients.

All your information will be kept confidential according to EEO guidelines.