Executive Director, Regulated Bioanalysis Leadership

Genentech

San Francisco (CA)

On-site

USD 255,000 - 473,000

Full time

14 days+

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Job summary

Genentech is seeking an Executive Director of Regulated Bioanalysis Implementation & Oversight (RBIO) to provide strategic, scientific, and organizational leadership for a critical function within the BioAnalytical Sciences (BAS) organization. This role ensures timely delivery of PK, immunogenicity, and biomarker data to support global regulatory submissions across nonclinical and clinical development.

You will lead RBIO's evolution to meet complex portfolio needs, partnering with BAS leaders

Qualifications

BS, MS, MBA, PhD, or equivalent degree in Biological Sciences, Chemistry, or a related discipline with 15+ years of relevant pharmaceutical or biotechnology industry experience supporting drug development and bioanalytical sciences, including significant leadership experience leading complex scientific and operational organizations across multiple organizational levels and influencing outcomes within a highly matrixed global environment.
Extensive experience providing scientific and operational leadership for regulated bioanalysis supporting pharmacokinetic, immunogenicity, and biomarker strategies across all phases of drug development.
Extensive experience developing and executing global bioanalytical outsourcing strategies, establishing and managing strategic CRO partnerships, and ensuring delivery of high-quality regulated bioanalytical studies w/e extensive experience partnering with global clinical study teams and overseeing regulated bioanalytical deliverables, including technical oversight, operational execution, and delivery of clinical study milestones.
Demonstrated scientific leadership supporting diverse therapeutic modalities, including biologics, antibody-drug conjugates, nucleic acid therapeutics, and emerging modalities such as cell and gene therapies.
Deep understanding of global regulatory requirements governing bioanalytical sciences, GxP compliance, sponsor oversight, quality systems, and regulated bioanalytical sample analysis.
Demonstrated ability to anticipate future scientific and operational needs while building organizational capabilities that support evolving portfolio requirements and emerging technologies. Experience evaluating and implementing innovative operating models, automation, connected data solutions, and AI-enabled approaches that improve scientific insight, operational performance, and organizational capability.
Proven ability to influence scientific and operational strategy while building strong partnerships across highly matrixed global organizations and external collaborators. Strong business acumen with demonstrated experience managing organizational budgets, resources, external partnerships, portfolio priorities, and long-term operational planning.
Outstanding communication, collaboration, and influencing skills with demonstrated ability to engage scientific, operational, and executive stakeholders and effectively lead through influence in a highly matrixed global environment w/p proven track record of developing leaders, building high-performing organizations, driving organizational change, fostering succession planning, and creating an inclusive culture of scientific excellence, continuous learning, collaboration, and innovation.

Responsibilities

Develop and execute the long-term vision and operating strategy for RBIO, ensuring the organization evolves alongside scientific innovation, emerging therapeutic modalities, changing regulatory expectations, and business needs.
Build future scientific, operational, and leadership capabilities that position RBIO to support increasingly complex bioanalytical and clinical development challenges.
Partner with BAS scientific leaders to translate evolving bioanalytical strategies into scalable operational capabilities that support emerging modalities and future portfolio needs.
Evaluate and implement innovative technologies, automation, connected data solutions, and AI-enabled scientific and operational approaches that improve operational efficiency, data integration, scientific insight, and decision-making.
Lead organizational change initiatives that improve agility, scalability, operational excellence, and resource efficiency while maintaining the highest standards of scientific quality and regulatory compliance.
Provide strategic oversight for implementation and execution of regulated and exploratory bioanalysis supporting nonclinical and clinical studies across the Genentech and Roche portfolios.
Ensure delivery of high-quality pharmacokinetic, immunogenicity, and soluble biomarker data through effective internal execution and global CRO partnerships.
Provide leadership and oversight of bioanalytical method transfer, assay lifecycle management, clinical sample operations, technical oversight of outsourced activities, and quality reagent delivery.
Ensure compliance with global regulatory requirements, Good Laboratory Practices (GLP), sponsor oversight expectations, internal quality systems, and applicable business processes.
Continuously evaluate opportunities to improve scientific, operational, and business processes while maintaining excellence in execution and delivery.
Develop and maintain strategic partnerships with global CROs, serving as BAS operational leader for external bioanalytical providers, shaping long-term scientific operational and innovation capabilities.
Establish long-term outsourcing strategies that provide scientific flexibility, operational scalability, access to emerging technologies, and efficient portfolio support.
Build strong collaborations across Research, Development Sciences, Product Development, Clinical Pharmacology, Clinical Operations, Clinical Data Management, DMPK, Quality, and other partner organizations to enable portfolio success.
Influence enterprise scientific and operational strategies through strategic partnerships across Genentech and Roche, ensuring alignment between organizational capabilities, portfolio priorities and future business needs.
Represent BAS on executive governance teams with external service providers and contribute to enterprise initiatives that strengthen scientific, operational, and business partnerships.
Lead, develop, and inspire a high-performing organization through effective coaching, succession planning, talent development, organizational design, and performance management.
Foster an inclusive culture of scientific excellence, collaboration, continuous learning, innovation, and accountability.
Build future leadership capability across RBIO through succession planning, mentorship, career development, strategic workforce planning, and development of future organizational leaders.
Create an environment that encourages thoughtful evaluation of scientific and operational practices, continuous improvement, and adoption of new technologies and approaches that strengthen RBIO's scientific and operational capabilities.
Accountable for strategic workforce planning, organization investments, budget stewardship, resource allocation and operation performance to maximize organizational effectiveness and portfolio delivery.
Support the gRED portfolio as well as gRED-originated therapeutics across the late-stage Global Product Development portfolio.
Partner with BAS leadership to establish departmental priorities and ensure alignment across BAS in support of the broader Development Sciences strategy.
Partner with BAS Leadership Team to shape organizational strategy, operating models, investment priorities, scientific capabilities and long-term workforce planning for BAS.
Support global regulatory submissions, due diligence activities, inspections, audits, portfolio integration efforts, and enterprise initiatives as required.
Serve as a strategic scientific and operational partner to BAS and enterprise leadership to ensure delivery of high-quality bioanalytical data supporting Genentech's innovative pipeline.