Global Head of Early Development Biometrics
Genentech
The Position
We advance science so that we all have more time with the people we love.
The Opportunity
As the Global Head of Early Development Biometrics, you will will provide strategic leadership and oversight across Biometrics functions – e.g., Biostatistics, Statistical and Analytical Programming, Data Management – to ensure a cohesive and high-performing collective function that drives excellence in service of our strategy through deep partnership with Roche early development groups. You will also oversee Biometrics-wide capabilities including innovative methods and analytical / digital enablers embedded within our workflows and processes. You will report to the Global Head, PD Data Sciences & Analytics (PD-DSA), and you will be responsible for shaping the early development strategy across all core Biometrics capabilities and therapeutic areas in alignment with broader PD-DSA and company objectives, as well as your organization's overall performance.
You will shape the strategy and execution for early development trials at Roche by partnering closely and influencing activities across Biostatistics, Statistical and Analytical Programming, and Data Management as they pertain to the early development portfolio. You will ensure scientific rigor, innovative approaches, and high-quality data solutions, all in service of accelerating decision-making and insights generation for early-phase clinical trials. Your team will leverage cutting-edge analytics, data standards, and automation to ensure delivery of timely, high-quality insights that inform critical decisions in early drug development.
You will lead a global, high-performing organization of approximately 75-100 early development-focused professionals, including Biostatisticians, Statistical Programmers, and Data Managers, to support the unique demands of early development. Your direct reports will be a team of directors and above. Reporting to the Global Head, PD Data Sciences & Analytics, you will have a direct line to influence and contribute to the overall strategy and success of early stage development programs at Roche.
PD-DSA SHARED LEADERSHIP OBJECTIVES
Develop and set a clear PD-DSA strategy and goals that align with Roche’s broader objectives, ensuring that you integrate Roche’s One Pharma strategy, PD goals, and R&D Excellence methods into the strategic direction
Embed and drive the adoption of PD-DSA’s strategic imperatives of Data, Digital/AI, and Design (the 3Ds) across your teams’ workflows, taking ownership of this mindset shift to ensure a seamless integration of these principles into daily operations
Act as a role model for your teams by delivering excellence in all aspects of your work (what you do, how you do it, and the impact you have), fostering a culture of learning, growth, and continuous improvement that empowers team members to reach their potential
Define and create clear accountability across each function in your organization and beyond, ensuring that you work in lock-step with your colleagues and partners to maintain alignment and drive cross-functional collaboration
Leadership and Strategy
Provide strategic leadership and oversight across all early development studies, ensuring a consistent and high-quality approach to Biometrics across all therapeutic areas
Lead a team of approximately 75-100 leaders across a global organization, driving strategy and execution with key stakeholders
Develop and implement a comprehensive integrated Biometrics strategy with a lens of early development and data science excellence that aligns with Roche’s research and early development objectives
Provide expert guidance to clinical development teams on study design, statistical methodology, and key decision-making processes (e.g., PivGo) to optimize early development pathways and inform data-driven decisions across the lifecycle of clinical trials
Partner with cross-functional leaders to develop and align Biometrics capabilities (e.g., innovative methods and analytical / digital enablers) across workflows with evolving scientific priorities and business needs
Evaluate challenges as they arise and direct them to the appropriate decision-makers for resolution; own resolutions as relevant
Lead the development and validation of innovative Biometric methods, partnering with senior leaders across early- and late-stage development for key use cases and embedding plans across development
Stakeholder Engagement and Partnerships
Act as the primary liaison between PD-DSA and key stakeholders across early development to drive alignment and shape outcomes for shared objectives
Ensure seamless collaboration between PD-DSA and internal early development stakeholders (e.g., gRED, pRED, informatics) and external collaborators to ensure portfolio excellence
Represent biometrics at cross-functional meetings, regulatory interactions, and industry forums, advocating for innovative approaches to early development
Shape early development strategies by providing data-driven insights and recommendations to cross-functional teams and senior leadership
Provide biometrics expertise to support the design and execution of Phase I and II clinical trials in service late-stage success
Partner across early development groups and with late-stage PD-DSA teams to ensure the seamless data flow and integration between early and late-stage development programs
Technical Excellence
Lead Biometrics activities, ensuring scientifically innovative study designs, analyses, and interpretations for early development trials
Oversee early development statistical programming deliverables, including data standardization, analysis datasets, and submission outputs, allowing for flexible real-time early trial reporting while ensuring compliance with global regulatory requirements
Define and implement data management strategies for planning, acquisition, and FAIRification of diverse data types, ensuring data quality and governance across early development
Drive the adoption of advanced analytics, automation, and data integration tools to enhance efficiency and insights generation
Talent Development
Lead, inspire, and develop a high-performing global team of early development Biostatisticians, Statistical Programmers, Data Managers, and innovators, ensuring their continued professional growth and ability to drive strategic impact
Establish a strong culture of accountability, innovation, and continuous learning within early development Biometrics functions
Define clear performance metrics and success criteria for the Early Development Biometrics function, ensuring alignment with organizational goals
Track performance metrics for the team’s overall success, ensuring alignment with organizational goals and driving continuous improvement, while providing professional development opportunities for team members
Partner with P&C and leadership to attract, retain, and develop top Biometrics talent to support long-term organizational success
Who You Are
MSc, PhD, or other advanced degree in Biostatistics, Statistics, Data Management, Computer Science, or a related field
More than 15 years experience (significant experience working at a senior level) in the pharmaceutical/biotech industry with an emphasis in early development Biometrics; ability to consult and understand medical issues (highly preferred with experience leading Biometrics in a small- to mid-sized Biotech focused on early-stage assets)
In-depth knowledge of Good Clinical Practice (GCP), international and in-country regulations, guidelines and their application, and all other applicable compliance standards related to data and statistical sciences and industry conventions
Proficiency in statistical programming languages and tools (e.g., SAS, R, Python) and data management systems (e.g., EDC systems, CDISC standards)
Strong understanding of clinical trial design, data collection, and regulatory requirements
Experience and understanding the new trends with all relevant data types (e.g., multi-modal data) and analytics
Thorough understanding of the end-to-end drug development lifecycle, particularly on elements involving data and statistical sciences, advanced analytics methods and data visualization tools and techniques
Proven experience in leading and managing high-performing teams
Strong strategic thinking and problem-solving skills
Experience driving cross-functional collaborations within the life sciences or healthcare industry, specifically working across early and late stage development organizations
Excellent communication and interpersonal skills
Ability to stay abreast of the latest trends and advancements in biometrics and clinical trial methodologies
Willingness to adopt new technologies and methodologies, in-depth experience in AI and digital advancements
Track record of establishing successful internal and external partnerships with relevant partner organizations and able to act as an ambassador for Roche
Influential and confident communicator
Strong English language skills
International travel as required - estimated at 20%
Relocation benefits are available for this job posting.
The expected salary range for this position based on the primary location of South San Francisco, CA is $307,800 - $571,600. 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, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.