Associate Director Clinical Development, Immunology
Biogen
August 20, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Associate Director, Clinical Development (Immunology)
Role Responsibilities:
- Partner with cross-functional teams (clinical operations, biostatistics, data management, regulatory, 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 to ensure patient safety.
- Serve as a contact for CROs and investigators for protocol-related questions.
- Provide scientific therapeutic expertise to internal/external stakeholders.
- Support data interpretation and clinical reporting for early phase studies.
- Support health authority interactions and responses to regulatory questions.
- Contribute scientific content to clinical protocols and other clinical development documents (protocols, amendments, investigator brochure, clinical study reports, briefing materials).
- Support risk mitigation strategies and provide clinical input for safety management plans.
- Champion patient-centered development approaches in study design.
- Monitor the external landscape in neuroimmunology and autoimmune disease.
Qualifications:
- MD/DO (or international equivalent) or PharmD with relevant experience (subspecialty experience in neurology/neuromuscular medicine or prior drug development in neuromuscular/neuroimmunology strongly preferred).
- 0–2+ years’ biotech/pharma experience (plus academic/clinical research experience).
- Prior experience in medical monitoring or investigator/sub-investigator role.
- Experience with clinical study execution/oversight and cross-functional work with R&D.
Required Skills:
- Strong written and verbal communication.
- Deep scientific and clinical understanding of neuroimmunology/autoimmune disorders.
- Ability to manage multiple priorities in a fast-paced environment.
- Domestic and international travel as required.
Preferred Skills:
- Relevant disease area experience (e.g., myasthenia gravis, CIDP, neuroimmunology/immune-mediated conditions).
- Understanding of regulatory requirements for drug development.
- Established network of global Key Opinion Leaders (KOLs).
Location/Work Options:
- Open to remote U.S.-based talent; preference for candidates near West Coast site in California.
Role Responsibilities:
- Partner with cross-functional teams (clinical operations, biostatistics, data management, regulatory, 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 to ensure patient safety.
- Serve as a contact for CROs and investigators for protocol-related questions.
- Provide scientific therapeutic expertise to internal/external stakeholders.
- Support data interpretation and clinical reporting for early phase studies.
- Support health authority interactions and responses to regulatory questions.
- Contribute scientific content to clinical protocols and other clinical development documents (protocols, amendments, investigator brochure, clinical study reports, briefing materials).
- Support risk mitigation strategies and provide clinical input for safety management plans.
- Champion patient-centered development approaches in study design.
- Monitor the external landscape in neuroimmunology and autoimmune disease.
Qualifications:
- MD/DO (or international equivalent) or PharmD with relevant experience (subspecialty experience in neurology/neuromuscular medicine or prior drug development in neuromuscular/neuroimmunology strongly preferred).
- 0–2+ years’ biotech/pharma experience (plus academic/clinical research experience).
- Prior experience in medical monitoring or investigator/sub-investigator role.
- Experience with clinical study execution/oversight and cross-functional work with R&D.
Required Skills:
- Strong written and verbal communication.
- Deep scientific and clinical understanding of neuroimmunology/autoimmune disorders.
- Ability to manage multiple priorities in a fast-paced environment.
- Domestic and international travel as required.
Preferred Skills:
- Relevant disease area experience (e.g., myasthenia gravis, CIDP, neuroimmunology/immune-mediated conditions).
- Understanding of regulatory requirements for drug development.
- Established network of global Key Opinion Leaders (KOLs).
Location/Work Options:
- Open to remote U.S.-based talent; preference for candidates near West Coast site in California.