Associate Director Clinical Development, Immunology

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

About This Role

The Associate Director Clinical Development, Immunology, based within Biogen’s West Coast Hub (WCH), will contribute to the clinical trial design and execution of one or more Immunology programs, focus on early-phase (I-II) studies in autoantibody-driven disease such as myasthenia gravis and chronic inflammatory demyelinating polyneuropathy (CIDP). Reporting to Sr Director Clinical Development Lead Immunology and Indications Expansion (WCH). The Associate Director, Clinical Development is a pivotal role requiring strong blend of scientific acumen, tactical trial execution, and collaborative leadership. Your primary responsibilities will include contributing to clinical development frameworks for new indications, designing robust protocols, and interpreting study data in clos partnership with internal research and development teams. As a key member of the clinical development team, you will execute key trials that drive the trajectory of our WCH immunology pipeline. You will also support the company’s broader mission by providing clinical insights to early-stage research assets, external partnerships, and due diligence activities.

What You’ll Do

• 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 to provide responses for protocol related questions.
• Provide scientific therapeutic expertise to internal and external stakeholders.
• Support data interpretation and clinical reporting for early phase clinical studies.
• Support preparation for health authority interaction and contribute to responses for regulatory questions related to clinical development activities.
• Contribute scientific contents for clinical protocols and other clinical development documents.
• Support risk mitigation strategies and provide clinical input for safety management plans Assist in providing scientific content for clinical study documents such as protocols, amendments, investigator brochure, clinical study reports, and briefing materials.
• Champion patient-centered development approaches by incorporating disease burden, feasibility and patient experience considerations into study design.
• Monitor the external landscape in neuroimmunology and autoimmune disease, including competitive intelligence, evolving standards of care, and relevant scientific advances.

Who You Are

You are passionate about advancing clinical development in immunology and improving the lives of patients with immune-mediated or autoimmune diseases. You thrive in ambiguity and continuously seek to learn and improve. Your expertise