Executive Director, Regulated Bioanalysis Implementation & Oversight (RBIO), BioAnalytical Sciences (Biotechnology)

Location: South San Francisco, California, United States of America. Relocation benefits are available.

Salary: $254,500–$472,700 per year

Company

hirify.global is a biotechnology company and member of the Roche group focused on discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Set the long-term scientific, operational, and organizational strategy for regulated bioanalysis implementation and oversight.
• Oversee regulated and exploratory bioanalysis supporting nonclinical and clinical development, including pharmacokinetic, immunogenicity, and biomarker data delivery.
• Lead global CRO portfolio management, outsourcing strategies, method transfers, assay lifecycle management, clinical sample operations, and quality reagent delivery.
• Ensure compliance with global regulatory requirements, GLP, sponsor oversight expectations, and internal quality systems.
• Evaluate automation, connected data solutions, and AI-enabled approaches to improve efficiency, data integration, and decision-making.
• Build partnerships across hirify.global, Roche, research, development, clinical, quality, and external service-provider organizations.

Requirements

• BS, MS, MBA, PhD, or equivalent degree in Biological Sciences, Chemistry, or a related discipline.
• 15+ years of relevant pharmaceutical or biotechnology industry experience in drug development and bioanalytical sciences.
• Significant leadership experience managing complex scientific and operational organizations in a highly matrixed global environment.
• Extensive experience with regulated bioanalysis, pharmacokinetic, immunogenicity, biomarker strategies, clinical studies, and global CRO partnerships.
• Deep understanding of global regulatory requirements, GxP compliance, sponsor oversight, quality systems, and regulated sample analysis.
• Must work in the United States, with the primary location in California.

Culture & Benefits

• Leadership role within the BioAnalytical Sciences organization and gRED senior leadership community.
• Focus on scientific excellence, continuous learning, innovation, collaboration, accountability, and inclusion.
• Relocation benefits are available for this posting.
• hirify.global is an equal opportunity employer.