Executive Director, Regulated Bioanalysis Implementation & Oversight (RBIO)

About the role

The Executive Director of Regulated Bioanalysis Implementation & Oversight (RBIO) leads a critical function in the BioAnalytical Sciences (BAS) organization within Genentech Early Research and Development (gRED). RBIO ensures timely delivery of high-quality pharmacokinetic (PK), immunogenicity and soluble biomarker data that support global regulatory submissions, from early development through post-marketing. The role sits on the BAS Leadership Team and the gRED Senior Leader community, combining operational excellence with strategic vision.

Key responsibilities

• Develop and execute RBIO's long-term vision and operating strategy, building scientific, operational and leadership capabilities for emerging modalities such as biologics, ADCs, nucleic acid therapeutics and cell and gene therapies.
• Evaluate and implement technologies, automation, connected data solutions and AI-enabled approaches to improve efficiency and decision-making.
• Lead organizational change initiatives that improve agility, scalability and resource efficiency while keeping quality and compliance standards.
• Oversight of regulated and exploratory bioanalysis, PK, immunogenicity and biomarker data delivery, and global CRO partnerships.
• Lead bioanalytical method transfer, assay lifecycle management, clinical sample operations, technical oversight of outsourced activities and quality reagent delivery.
• Ensure compliance with global regulatory requirements, GLP, sponsor oversight expectations and internal quality systems.
• Build strategic partnerships with global CROs, set long-term outsourcing strategies and collaborate with Research, Development Sciences, Product Development, Clinical Pharmacology, DMPK, Quality and others.
• Represent BAS on executive governance teams with external service providers and influence enterprise scientific and operational strategy.
• Lead, coach and develop the RBIO team through succession planning, talent development and performance management, and foster an inclusive culture of excellence and continuous improvement.
• Own strategic workforce planning, budget stewardship and resource allocation, and support late-stage global product development, regulatory submissions, due diligence, inspections and audits.