Data Management TA Lead, Early Development

Overview A healthier future drives us to innovate. We continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. In Early Development Biometrics (EDB), a core function within Product Development Data Sciences (PDD), we provide strategic leadership and scientific rigor across early clinical development at Roche. We partner across Biostatistics, Analytical Data Science, and Data Management to enable data‑driven decision‑making from first‑in‑human through proof‑of‑concept studies. Our integrated teams operate with agility and scientific depth, supporting exploratory analyses, early regulatory engagements, and complex data‑generation needs across therapeutic areas. EDB also houses Methods Collaboration & Outreach (MCO), which enables the most impactful use of quantitative methodology across PDD through internal consultation, external collaboration, and continuous capability building; and Visual Analytics, which creates and maintains interactive dashboards that drive high‑quality Medical Data Review (MDR) and safety signal detection, aligned with Risk‑Based Quality Management (RBQM) principles and Critical‑to‑Quality (CtQ) endpoints. Opportunity The Data Management TA Lead in Early Development Biometrics is accountable for setting and executing the data management strategy across a therapeutic area (TA), ensuring high‑quality, reliable, and analysis‑ready data in support of early‑phase clinical development. This role directly leads a team of 6–8 Data Managers, partnering closely with Biostatistics, Data Science, Clinical Operations, and vendor teams. Key responsibilities include: Provide strategic leadership for data management across a therapeutic area, ensuring data strategies align with scientific objectives and evolving program needs. Design and drive implementation of fit‑for‑purpose data practices that support flexible study designs, exploratory endpoints, and rapid iteration. Anticipate and solve complex challenges involving non‑standard data, external data sources, and limited precedent, ensuring readiness for internal and downstream decision‑making. Lead alignment across biometrics contributors (e.g., data standards, statistical programming) to ensure consistency, efficiency, and data reusability across early‑phase programs. Represent Early Development Data Management in internal forums focused on functional excellence, capability development, and process innovation. Set quality expectations and provide expert guidance across studies, serving as a senior advisor and mentor to study‑level data managers and other data contributors. Manage team workload, capacity planning, and study allocation based on program complexity and milestones. Foster collaboration and information sharing across study teams and with cross‑functional partners. Represent data management in molecule‑level or DA‑level forums and ensure alignment with clinical and data science strategies. Co‑model effective leadership behaviors and coach team members to grow technical, leadership, and strategic skills. Serve as a role model in demonstrating Roche’s Leadership Commitments and the Pharma Operating Principles. Work with other DM TA Leads and People Leaders within Early Development Biometrics, Data Management, and across PDD to support continued development of the PDD talent pipeline through training, mentoring, and coaching. Who You Are • Bachelor’s or Master’s degree in life sciences, informatics, statistics, computer science, or a related field.• 12+ years of experience in clinical data management, with a focus on complex or novel data types in early‑phase development.• Recognized as an expert in data strategy, standards, and quality frameworks for early‑stage clinical trials.• Deep understanding of data flow, collection, and transformation processes across the R&D ecosystem.• Ability to anticipate technical data challenges and design scalable solutions under conditions of scientific uncertainty.• Skilled in TA‑level data planning, study startup consultation, and enabling evidence readiness across multiple programs.• Excellent written and verbal communication skills, with the ability to clearly articulate technical concepts and implications to internal audiences.• Strong expertise in CDISC standards, regulatory requirements, and clinical data systems (e.g., EDC, eCOA, lab systems).• Experience mentoring and developing team members, with strong performance‑management skills.• Operates independently, makes strategic trade‑offs, and manages cross‑study resource planning.• Demonstrates respect for cultural differences when interacting with colleagues in the global workplace. Preferred Qualifications Expertise in early development data strategies, including handling of exploratory endpoints, biomarker data, and adaptive trial designs. Experience supporting early‑phase regulatory submissions (e.g., IND, CTA) and preparing data for downstream readiness. Demonstrated leadership in evolving data management practices (e.g., modular CRFs, flexible standards, decentralized data sources). Proven ability to mentor or advise study‑level data managers, raising overall quality and consistency across a TA. Awareness of emerging industry practices (e.g., automation, FAIR data, AI‑assisted QC) and ability to translate them into fit‑for‑purpose functional improvements. Benefits • Salary range for California: $165,100–$306,500 (actual pay determined by experience, qualifications, geographic location, and other job‑related factors).• Discretionary annual bonus may be available based on individual and company performance.• Eligible for benefits detailed at the company portal.• Relocation benefits are not available for this posting. Equal Opportunity Employer Genentech, a member of the Roche group, is an equal‑opportunity employer. We employ, promote, and treat all employees and applicants on the basis of merit, qualifications, and competence. Our policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of protected veteran status, disability 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. #J-18808-Ljbffr F. Hoffmann-La Roche AG