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Associate Director, In Vivo Digital Portfolio & Data Stewardship

Takeda
Full-time
Remote friendly (Boston, MA)
United States
$153,600 - $241,340 USD yearly

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Role Summary

Associate Director, In Vivo Digital Portfolio & Data Stewardship: drive digital enablement and data quality across our preclinical in vivo research organization, bridging science, operations, and technology to ensure seamless integration of study workflows, regulatory compliance, and data interoperability.

Responsibilities

  • Digital Strategy & Roadmap: Partner with Research, digital (RDDT) teams to define and implement the digital vision for in vivo workflows.
  • Preclinical Study Workflow Support: Guide the design and optimization of study processes, spanning protocol setup, randomization, dosing, in life data collection, observations, sample collection, necropsy, and reporting.
  • Data Stewardship & Interoperability: Ensure robust data standards and harmonization (animal IDs, sample IDs, study IDs) across systems such as Benchling In Vivo, Tetrascience, Pristima, and Studylog, enabling seamless interoperability with sample registration, study identification, and electronic lab notebooks (eLN).
  • Integration of CRO Datasets: Lead the ingestion, mapping, and standardization of external CRO-generated in vivo datasets into internal workflows (e.g., Benchling In Vivo), ensuring data consistency, regulatory alignment, and reusability for downstream analytics.
  • Vivarium Operations & Compliance: Support digital workflows in animal care, cage/room management, and compliance with IACUC/GLP standards.
  • Cross-Functional Collaboration: Serve as a trusted partner across Research Units, Digital R&D, Quality, and Operations to ensure business needs are aligned with digital delivery.
  • Audit & Data Integrity: Champion ALCOA+ principles, ensuring audit-readiness of all in vivo data and compliance with electronic record-keeping regulations.
  • Metrics & Adoption: Define, monitor, and report on study-level KPIs (e.g., cycle times, missed observations, protocol deviations, adoption rates).

Qualifications

  • Required: Deep understanding of in vivo preclinical study workflows; knowledge of vivarium operations (cage/room management, animal identification, regulatory compliance - IACUC, GLP); proven expertise in data modeling and interoperability for animal and procedure-level data across digital platforms; strong communication skills to translate complex workflows into digital requirements; experience with Benchling In Vivo, Benchling eLN, Pristima, Studylog; demonstrated leadership in cross-functional alignment and adoption of new tools and standards; Bachelor’s or Master’s degree in Life Sciences, Data Science, or related field; 5–10 years’ experience in Pharma/Biotech with focus on preclinical in vivo research and digital enablement/data stewardship.
  • Preferred: Experience in therapeutic area–specific in vivo workflows; PKPD modeling; exposure to safety/toxicology and pathology data workflows; domain-specific testing and QA in digital tools for in vivo research; familiarity with dosing, tumor measurements, body weights, and clinical observations; proficiency in Japanese; ability to translate technical concepts into business relevance.

Skills

  • Digital strategy and program management
  • Data stewardship, interoperability, and standards (e.g., animal/sample/study IDs)
  • Workflow design and optimization for preclinical in vivo studies
  • Experience with Benchling In Vivo, Benchling eLN, Pristima, Studylog
  • Regulatory compliance knowledge (IACUC, GLP)
  • Strong cross-functional collaboration and stakeholder management
  • Audit-readiness and ALCOA+ data integrity

Education

  • Bachelor’s or Master’s degree in Life Sciences, Data Science, or related field

Additional Requirements

  • Location: Boston, MA
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