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

F. Hoffmann-La Roche AG; South San Francisco (CA); On-site; USD 254,500 - 472,700; Full time

Benefits offered by this job

Relocation benefits available

Discretionary annual bonus

Comprehensive benefits package

Job summary

Genentech, a member of the Roche group, seeks an Executive Director of Regulated Bioanalysis Implementation & Oversight (RBIO) to lead scientific and operational excellence across PK, immunogenicity, and biomarker data for nonclinical and clinical programs.

The role requires 15+ years in pharma/biotech with strong CRO collaboration experience, regulatory acumen, and a track record of building high-performing teams in a global matrixed environment.

Qualifications

• Extensive leadership experience in regulated bioanalysis and drug development.
• Proven track record with global CRO partnerships and outsourcing.
• Deep understanding of GLP, regulatory requirements, and quality systems.

Responsibilities

• Provide strategic, scientific, and organizational leadership for RBIO within BAS.
• Oversee bioanalytical strategies across nonclinical and clinical development.
• Drive partnerships with CROs and external collaborators to deliver high-quality data.
• Lead organizational change, budget stewardship, and workforce planning.

Skills

Strategic leadership

Bioanalytical sciences

Regulatory compliance

Global CRO partnerships

Outsourcing strategy

Education

Advanced degree (BS/MS/MBA/PhD) in Biological Sciences or related field

Job description

We advance science so that we all have more time with the people we love. The Executive Director of Regulated Bioanalysis Implementation & Oversight (RBIO) provides strategic, scientific, and organizational leadership for a critical function in the BioAnalytical Sciences (BAS) organization within Genentech Early Research and Development (gRED) . RBIO enables the successful implementation of bioanalytical strategies across nonclinical and clinical development by ensuring the timely delivery of high-quality pharmacokinetic (PK), immunogenicity, and soluble biomarker data that support global regulatory submissions and advance Genentech's diverse portfolio from early development through post-marking. As an integral member of the BAS Leadership Team, the Executive Director is responsible for evolving RBIO's scientific, operational, and leadership capabilities to meet the needs of an increasingly complex portfolio that includes biologics, antibody-drug conjugates, nucleic acid therapeutics, and advanced modalities such as cell and gene therapies. This role combines operational excellence with strategic vision, ensuring that RBIO continues to evolve alongside advances in science, technology, regulatory expectations, and modern operational capabilities while maintaining the highest standards of scientific excellence, quality, and compliance. The RBIO organization translates BAS scientific strategy into high-quality bioanalytical execution through strategic external partnerships, robust operational oversight, and delivery of regulated bioanalytical data supporting nonclinical and clinical development. Through its integrated capabilities in global CRO portfolio management, clinical bioanalysis operations, and quality reagent solutions, RBIO enables the generation of foundational pharmacokinetic, immunogenicity, and biomarker data while advancing operational excellence, scientific innovation, and scalable capabilities that support Genentech's increasingly complex portfolio. The Executive Director partners closely with leaders across Research, Development Sciences, Early Clinical Development, Product Development, Clinical Pharmacology, DMPK, Translational Medicine, and the broader Roche organization to ensure RBIO delivers innovative, scalable, and efficient bioanalytical solutions that accelerate development of transformative medicines for patients. As a member of the BAS Leadership Team, this leader helps translate BAS scientific strategy into organizational capability while fostering a culture of scientific excellence, learning, innovation and continuous improvement. Additionally, the Executive Director will be a member of the gRED Senior Leader community working alongside their peers to support enterprise-wide organizational strategies and change management initiatives.

The Opportunity:

The Executive Director is responsible for the strategic, scientific, operational, and organizational leadership of RBIO, including but not limited to:

Strategic Leadership

• 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.

Scientific and Operational Excellence

• 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 life‑cycle 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.

External Partnerships and Enterprise Influence

• Develop and maintain strategic partnerships with global contract research organizations (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.

Organizational Leadership

• 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.

Portfolio Delivery and Governance

• Accountable for strategic workforce planning, organizational 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.

Who You Are:

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/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/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.

Benefits

• Relocation benefits are available for this posting.
• The expected salary range for this position based on the primary location of California is $254,500 -$472,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world’s most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.