TL;DR
Data Management TA Lead (Biotech): Setting and executing the data management strategy across a therapeutic area, ensuring high-quality, reliable, and analysis-ready data in support of early-phase clinical development with an accent on flexible study designs, exploratory endpoints, and rapid iteration. Focus on challenges involving non-standard data, external data sources, and limited precedent, ensuring readiness for internal and downstream decision-making.
Location: South San Francisco, California, United States of America
Salary: $165,100-$306,500
Company
hirify.global is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases.
What you will do
- Provide strategic leadership for data management across a therapeutic area in early development, aligning data strategies 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.
- 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.
- Lead and develop a team of Data Managers supporting multiple studies across one or more molecules within a subset of a disease area.
Requirements
- Hold a Bachelor’s or Master’s degree in life sciences, informatics, statistics, computer science, or a related field.
- Bring 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.
- Have a deep understanding of data flow, collection, and transformation processes across the R&D ecosystem.
- Demonstrate the 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.
Nice to have
- 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.
Culture & Benefits
- hirify.global is an equal opportunity employer.
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