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, owning benefit/risk and clinical strategy for multiple sclerosis and neuromuscular disease.
Role type
Senior IC Global Clinical Program Lead
Builds
Immune-reset therapies for immune-mediated neurological diseases
Domain
Biopharmaceuticals R&D / Neuroimmunology / Neuromuscular disease
Required skills
Clinical drug development leadership, Study design and delivery, Program safety leadership, Regulatory interactions, Cross-functional matrix leadership, Scientific surveillance
Preferred skills
Neuroimmunology or neuromuscular disease subspecialty training, Immune-reset therapy experience, CMC-clinical interface knowledge
Technologies
FDA, EMA, MHRA, ICH GCP
Responsibilities
Define and drive clinical/scientific strategy including Target Product Profile; Lead endpoint strategy and innovative trial designs; Set and oversee program-level safety strategy; Own clinical content for regulatory submissions; Present data-driven program updates to governance committees; Build relationships with external experts, investigators, and patient partners.
Seniority
Senior, hands-on IC