Jobs at Biogen

The Senior Director of Regulatory Affairs will lead global regulatory strategy for biopharmaceutical development, ensuring successful progression from early to late stages and interacting with health authorities.

As the Head of Clinical Pharmacology & Pharmacometrics, lead strategic oversight across clinical development, ensuring scientific quality and regulatory compliance. Guide dose optimization, lifecycle management, and MIDD strategies while mentoring a high-performing team. Collaborate with cross-functional leaders to influence portfolio strategy and drive decision-making.

Lead design and execution of in vitro and in vivo immunology studies to identify and validate drug targets, biomarkers, and immune pathways. Develop and optimize cellular, biochemical, and functional assays using primary cells and patient samples, analyze complex datasets, support translational strategy, collaborate cross-functionally, and evaluate external scientific opportunities to advance immunology drug discovery programs.

The Principal Scientist will develop biomarker strategies for clinical studies, oversee data interpretation, collaborate with cross-functional teams, and contribute to regulatory submissions in the field of solid organ transplant research.

Lead biologics discovery efforts, manage and grow a scientific team, drive antibody engineering and molecular design strategies, partner cross-functionally to advance discovery programs, evaluate external innovations, and support candidate selection and translational assessments.

The Study Manager leads biomarker and bioanalytical operations across clinical studies, ensuring high-quality data delivery and compliance during drug development.

Lead and oversee statistical programming activities, ensuring compliance with standards, managing deliverables, and implementing data strategies. Serve as an expert in statistical programming while guiding projects and improving processes.

Own and administer Biogen's Small Business Subcontracting Plan (SBSP), ensure federal compliance and audit readiness, maintain supplier diversity data, integrate ESG/diversity into sourcing decisions, support sourcing teams, perform spend analytics, produce government and ESG reports, and represent the company in supplier diversity networks.

Manage global site contract strategy and execution for Phase I-IV clinical trials. Oversee CRO compliance and payments, resolve complex negotiations with R&D Legal, support country-level contract strategy, refine tools and templates, provide training, and ensure adherence to GCP/ICH/FDA/EMA standards.

Lead biostatistical efforts in clinical research, oversee analysis plans, mentor junior staff, and ensure statistical integrity. Key role in data analysis and regulatory submissions.

The Associate Scientific Director will lead pharmacometrics analyses, contribute to drug development strategies, mentor colleagues, and support decision-making through advanced quantitative modeling.

Lead clinical development activities for early-phase neuroimmunology programs (I-II). Design protocols, provide medical monitoring, oversee study execution, collaborate cross-functionally and with CROs, support regulatory interactions, interpret data, and incorporate patient-centered approaches to advance immunology drug candidates.

Oversee clinical pharmacology plans for drug candidates, lead studies, analyze pharmacokinetic data, and engage with health authorities to guide drug development strategies.

Lead end-to-end in-house site feasibility for clinical trials, manage cross-functional stakeholders, run outreach via site questionnaires, perform data-driven feasibility analyses and site ranking, create visualizations and reports, maintain feasibility databases, and support scenario modeling for trial operational designs.