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  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.

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.

• 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…