Senior Principal Scientist, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine
Core
Designing and implementing late-stage clinical biomarker and translational medicine plans for neuroscience therapeutics to support regulatory submissions and drug development.
Role type
Senior Principal Scientist, Translational Medicine (Neuroscience)
Builds
Clinical protocols, Standard Operating Procedures (SOPs), Study Outlines (SOWs), and lab manuals for late-stage trials.
Domain
Biopharmaceuticals, Neuroscience, Translational Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Late-stage clinical biomarker strategy, assay selection and vendor management, clinical trial design, regulatory interaction, scientific literature evaluation, cross-functional team leadership, project timeline management
Preferred skills
Experience with CRO management, academic collaboration, post-hoc data analysis, publication preparation
Technologies
None explicitly listed
Responsibilities
Design and implement program-specific late development biomarker/translational plans; Determine appropriate assays and vendors for clinical biomarkers; Manage clinical biomarker data delivery and analysis; Prepare and deliver internal and external translational/biomarker presentations; Maintain timelines for biomarker data related publication; Keep up-to-date on relevant scientific/technical literature; Work with TM laboratory scientists and academic TLs to address nonclinical translational questions; Support regulatory submissions and interactions
Seniority
Principal, strategy & mentorship
