Sr. Manager, Clinical Trial Lead​ 

📋 Description

• • As a Senior Manager, Clinical Trial Lead (CTL) at Biogen, you will be at the forefront of developing novel targeted therapies for severe immune-mediated diseases. This pivotal role, based remotely in the USA, empowers you to independently oversee one or more clinical studies, leveraging your extensive phase, indication, and operational expertise to drive transformative patient outcomes.
• • You will be instrumental in partnering with cross-functional representatives to architect operationally feasible and robust protocol designs. This involves a deep commitment to patient focus, rigorous risk management, unwavering quality standards, and scientific integrity, all while maintaining a keen eye on budget responsibility and cost-effectiveness aligned with study endpoints.
• • A core responsibility is the development and meticulous implementation of the study-level operational strategy. You will translate key operational aspects from the Integrated Development Plan and Global Program Strategy into actionable plans, ensuring the successful delivery of each protocol.
• • You will exercise high-level, data-driven oversight of Biogen’s Contract Research Organization (CRO) partners, ensuring excellence in execution and strict alignment with the agreed-upon strategy and associated plans. This includes managing performance, quality, and timelines to meet or exceed baseline plan expectations.
• • As the chair of the Study Management Team (SMT), you will guide the development of scientifically robust, operationally feasible, and clear protocol concepts and protocols. You will collaborate strategically with core SMT members, including study Medical Directors and biostatisticians, as well as other key program team members, providing critical direction on phase, disease, or therapeutic area to align study design with the overarching Integrated Development Plan and Global Program Strategy.
• • Your operational expertise and scientific acumen will be crucial in evaluating study feasibility and supporting protocol development. You will be adept at aligning diverse team perspectives to forge a cohesive cross-functional operational strategy, drawing upon current therapeutic knowledge and relevant supporting data.
• • A significant aspect of your role involves ensuring ongoing data review to proactively identify and mitigate potential issues related to patient safety, study design, data integrity, or study conduct. You will demonstrate strong financial management and analytical skills, ensuring budgets are scrutinized appropriately and align with study endpoint needs.
• • You will oversee the successful delivery of studies by CROs, ensuring quality execution within time and budget forecasts. In partnership with the CRO SMT Lead, you will ensure the CRO develops effective risk mitigation plans and is adept at proactively identifying and resolving issues.
• • You will establish and drive effective and efficient team operations by setting the SMT culture, ensuring thorough team communication, effective goal setting and management, and diligent oversight of strategy implementation. Your focus will be on ensuring all operational aspects of study conduct robustly support patient safety, endpoint integrity, and data validity.
• • You will exhibit a profound understanding of the study design, rationale, endpoints, and patient population. Through ongoing review of performance and partnership metrics, you will ensure key milestones and deliverables are achieved.
• • You will ensure that all project plans, such as the Monitoring Plan and Quality Plan, are effectively implemented for the successful execution of studies. You will lead the SMT in developing robust Baseline plans and ensure the team is thoroughly prepared for all key governance forums.
• • Proactive and robust management of inflection points is critical, ensuring any necessary course corrections are addressed swiftly and effectively. You will collaborate with Corporate Finance and Procurement functions to ensure Fair Market Value (FMV) is achieved and budget oversight responsibilities are met.
• • You will maintain data accuracy, completeness, and quality within study-related systems and strive for effective, consistent, efficient, and compliant processes across all study operations.
• • You will champion best practices and actively seek opportunities for innovation and efficiency within the Clinical Trial Development Unit (CTDU) and Global Clinical Operations (GCO). You will seek synergies with other studies, programs, and development units to enhance excellence in study planning and execution.
• • You will actively contribute to improving and streamlining processes to support the GCO CRO outsourcing models, providing valuable feedback for process enhancements and best practice establishment. You will embody a culture of continuous improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
• • You will advocate for the CTDU group and promote active interaction with other Biogen groups, contributing to a rich and diverse knowledge base within CTDU by sharing your Subject Matter Expertise (SME) where applicable.
• • This role is ideal for a scientifically and clinically astute, mission-driven individual with the strategic vision to see the big picture and assume responsibilities that extend far beyond day-to-day operations. If you are decisive, analytical, self-confident, and determined to own your career and make a significant difference in the lives of others through your leadership and ability to inspire excellence, this is the opportunity for you.