Immunology Clinical Development Leader - Early-Phase Trials

Biogen, Inc.; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Biogen, Inc. is seeking an Associate Director of Clinical Development in Immunology based at Biogen’s West Coast Hub (WCH). This role focuses on early-phase (I-II) studies in autoantibody-driven diseases such as myasthenia gravis and CIDP, contributing to trial design and execution.

You will collaborate with internal research and development teams to shape development frameworks, design robust protocols, and interpret study data to drive the immunology portfolio forward.

Qualifications

• Experience in early-phase clinical development and immunology
• Ability to design robust early-phase trial protocols
• Strong cross-functional collaboration and leadership in a matrix environment

Responsibilities

• Partner with cross-functional teams including clinical operations, biostatistics, data management, regulatory, and safety to advance early-phase development programs.
• Contribute to clinical trial protocol design, development and execution for early-phase neuroimmunology studies.
• Provide medical monitoring, clinical execution, and oversight of clinical studies to ensure patient safety; serve as a contact for CRO and investigators on protocol questions.
• Provide scientific therapeutic expertise to internal and external stakeholders.
• Support data interpretation and clinical reporting for early-phase studies.
• Support preparation for health authority interaction and contribute to regulatory responses.
• Contribute scientific content for protocols and other documents.
• Support risk mitigation and safety management plans; assist in producing study documents.

Skills

Clinical development

Immunology

Trial execution

Cross-functional leadership

Job description

Biogen, Inc. is seeking an Associate Director of Clinical Development in Immunology based at Biogen’s West Coast Hub (WCH). This role focuses on early-phase (I-II) studies in autoantibody-driven diseases such as myasthenia gravis and CIDP, contributing to trial design and execution.

You will collaborate with internal research and development teams to shape development frameworks, design robust protocols, and interpret study data to drive the immunology portfolio forward.