Executive Director, Regulated Bioanalysis Implementation & Oversight (RBIO), BioAnalytical Sciences
Core
Provide strategic, scientific, and organizational leadership for Regulated Bioanalysis Implementation & Oversight (RBIO) to ensure timely delivery of high-quality pharmacokinetic, immunogenicity, and biomarker data supporting global regulatory submissions.
Role type
Executive Director, Regulated Bioanalysis Implementation & Oversight
Builds
Regulated bioanalytical data (PK, immunogenicity, biomarkers) for nonclinical and clinical development
Domain
Biopharmaceuticals / Bioanalytical Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, operational oversight, CRO portfolio management, assay lifecycle management, regulatory compliance, organizational development, budget stewardship, change management
Preferred skills
Experience with biologics, antibody-drug conjugates, nucleic acid therapeutics, cell and gene therapies
Technologies
AI-enabled scientific and operational approaches, connected data solutions
Responsibilities
Develop and execute long-term vision and operating strategy for RBIO; Provide strategic oversight for implementation of regulated bioanalysis; Lead organizational change initiatives; Develop and maintain strategic partnerships with global CROs; Lead, develop, and inspire a high-performing organization; Account for strategic workforce planning and budget stewardship
Seniority
Executive, enterprise-level leadership
