· Provide clinical oversight and medical monitoring for one or more clinical trials in neurology and/or autoimmune disease.
· Contribute to the design and implementation of clinical studies, including early-phase and proof-of-concept trials, in collaboration with senior clinical leaders and cross-functional partners.
· Draft and/or review protocols, protocol amendments, investigator brochures, clinical study reports, informed consent forms, safety narratives, and other clinical trial documents.
· Participate in investigator meetings, site engagement activities, and selected site initiation activities with clinical trial investigators.
· Support execution of clinical development plans by identifying study risks, proposing mitigations, and helping track milestones, deliverables, and budget-conscious study decisions.
· Interpret findings from research, translational, and nonclinical studies and help translate them into clinical development opportunities.
· Interact with investigators, key opinion leaders, and other external experts to support protocol development, study conduct, and data interpretation.
· Partner with internal Regulatory Affairs, Safety, Clinical Operations, Biometrics, Translational Sciences, Medical Writing, and other functions to support high-quality study execution and regulatory compliance.
· Provide clinical input to regulatory submissions and responses to health authority questions in the context of INDs, clinical trial applications, and later-stage planning.
· Contribute clinical guidance in interactions with external stakeholders, including advisory boards and patient advocacy organizations, and with internal stakeholders across Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial as appropriate.
· May present scientific or clinical data at investigator meetings and scientific congresses and may contribute to abstracts, presentations, and publications.
· May support due diligence or clinical evaluation of external opportunities as needed.