Associate Director, Clinical Biomarkers Lead
Core
Lead clinical biomarker development strategies for immunology and neuromuscular therapeutic programs across the drug development lifecycle.
Role type
Senior management clinical biomarker lead
Builds
Clinical trial protocols, regulatory filings, and biomarker strategies for novel therapeutics
Domain
Biopharmaceuticals / Immunology / Neuromuscular diseases
Deliverable
client delivery
Required skills
PhD, 10+ years industry experience, 4+ years leading clinical biomarker strategies in immune-mediated diseases, matrix management, regulatory document authoring, cytometry and immunoassay technology expertise, strategic planning
Preferred skills
None stated
Technologies
Cytometry, immunoassay
Responsibilities
Develop and implement comprehensive biomarker strategies for pivotal/phase 3 programs, drive generation and interpretation of biomarker data, mentor team members, liaise with cross-functional stakeholders, build partnerships with academic and external collaborators, matrix manage assay development scientists and outsourced projects, support clinical trial planning and protocol authoring, engage with regulators via conferences and publications
Seniority
Management level, strategic oversight and team leadership
