Job DescriptionDevelop and oversee implementation of the study-level operational strategy for the successful delivery of complex clinical studies.Serve as Chair the Study Management Team (SMT) to drive the development of scientifically robust, operationally feasible, and clear protocol concepts/protocols.Collaborate strategically with the core SMT and other key program team members to provide direction on phase, disease, or therapeutic area to support study design in alignment with the Global Program Strategy, enabling protocol concept development and driving forward studies through governance approval.Leverage operational expertise and scientific assessment to evaluate study feasibility and support protocol development.Align team perspectives to develop a cross-functional operational strategy, leveraging expertise, current therapeutic knowledge, and relevant supporting data.Lead the study via oversight of the clinical research organization (CRO), and manage performance, quality, and timelines, including defining and delivering against a baseline plan.Ensure ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues, and maintain data accuracy, completeness, and quality within study-related systems.Ensure budgets hold up to appropriate scrutiny and align with study endpoint needs by leveraging advanced financial management and analysis skills.Establish and drive effective and efficient team operations by setting culture of SMT, ensuring thorough team communication, effective goal setting/management and oversight of strategy implementation.Ensure all operational aspects of the studies conduct support patient safety, endpoint integrity and data validity.Provide oversight via ongoing review of performance and partnership metrics to ensure key milestones and deliverables are achieved.Ensure that all project plans are in place for effective implementation of studies.Lead SMT to develop robust Baseline plans, and ensure team is prepared for all key Biogen study governance forumsSeek ways to improve and streamline organization processes.Promote a rich and diverse knowledge base within department, contributing subject matter expertise and leading evolution of core areas including but not limited to, Interviewing/Onboarding, SOP process review, and partnership development.Support program level work by helping to support early strategic planning for future studies in the program, developing early study strategies based on the program goals, and presenting plans at senior level meetings.10% domestic and international travel required.Telecommuting permitted up to 100%#LI-DNIQualificationsMinimum Requirements:Bachelor's degree (or foreign equivalent) in Biology, Chemistry, Nursing, Health/Medical Sciences, Pre-Med, or any health-related field and 8 years of progressive experience in the job offered or a Clinical Trial Lead-related occupation in Clinical operations within the Clinical Trial Project Management field. Experience must include: 8 years of experience with each of the following:Knowledge of clinical development within at least two Phases of trials (Phase I, II, III, or IV) and a working knowledge of cross-functional drug development.Utilizing scientific, operational, and project management
including risk assessment and contingency planning.Team leadership including building effective relationships across and up and down a matrix organization and partnering with other functions as well as internal and external stakeholders.Knowledge of GCP standards, ICH guidelines, and regulatory requirements for clinical development. 7 years of experience with each of the following:Developing a sound working knowledge of complex therapeutic areas including neurology, oncology, or cardiovascular.Utilizing CRO management skills, including establishing operational plans and supporting the CRO in the execution of the clinical trial plans.Additional InformationAll your information will be kept confidential according to EEO guidelines.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.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.PDN-98ed0502-346f-4e0a-8716-7e11b8b185c7