Global Clinical Program Lead – Neuroimmunology, Immunology, BioPharmaceuticals R&D
Core
Lead immune-reset programs in neuroimmunology and neuromuscular disease from first-in-patient to pivotal, defining clinical strategy and benefit/risk for people with immune-mediated neurological disease.
Role type
Senior IC Global Clinical Program Lead
Builds
Immune-reset therapies for multiple sclerosis and neuromuscular disease
Domain
Biopharmaceuticals R&D, Neuroimmunology, Immunology
Required skills
Clinical drug development leadership, Study design and delivery, Program safety leadership, Regulatory submissions and health authority interactions, Cross-functional matrix leadership, Scientific surveillance and innovation
Preferred skills
Neuroimmunology or neuromuscular disease subspecialty training, Immune-reset therapy experience (cell therapies, B-cell-directed therapies), CMC-clinical interface knowledge, Clinical/commercial interface experience
Technologies
FDA, EMA, MHRA, ICH GCP
Responsibilities
Define and drive clinical and scientific strategy including benefit/risk and Target Product Profile; Lead endpoint strategy and innovative trial designs; Set and oversee program-level safety strategy for immune-reset therapies; Own clinical content for IND/CTA submissions and lead health-authority interactions; Present data-driven program updates to internal governance committees; Build trusted relationships with external experts, investigators, and patient-advocacy groups; Provide day-to-day matrix leadership to study physicians and clinical scientists.
Seniority
Senior, hands-on IC