Director, Head of High-Throughput in vitro ADME

Role Summary

The Director, High-Throughput In Vitro ADME is a senior scientific and operational leader responsible for building and directing Takeda’s high-throughput in vitro ADME capabilities in support of small- and large-molecule discovery programs. The role defines strategy, oversees operations, and drives technology innovation at the interface of ADME science, laboratory automation, and robotics, delivering robust, high-quality ADME data to enable rapid, high-confidence decision-making in DMTA cycles across the portfolio. The position reports to the Head of Drug Discovery Lab Automation and Transformation.

Responsibilities

• Strategic Leadership & Vision:
  • Define and execute the multi-year strategic roadmap for high-throughput in vitro ADME at Takeda, aligned with the broader Drug Discovery Lab Automation and Transformation organization.
  • Shape an enterprise-level, service-oriented operating model for ADME, ensuring capacity, capability, and flexibility to meet evolving project and portfolio needs.
  • Champion innovation in high throughput assay design, detection technologies, automation, and data workflows to enhance throughput, quality, and cost-effectiveness.
• Team Leadership & People Development:
  • Lead, mentor, and grow a team of scientists and research associates responsible for the routine delivery of a comprehensive suite of in vitro ADME assays.
  • Build a culture of scientific rigor, operational excellence, safety, and customer focus, supported by clear KPIs (e.g., cycle time, success rate, capacity utilization, cost-per-data point).
  • Drive talent development and performance management appropriate for a Director-level organization.
• High-Throughput ADME Operations:
  • Oversee design, execution, and continuous improvement of a broad high-throughput in vitro ADME panel, including but not limited to metabolic stability and clearance (microsomes, hepatocytes, S9), CYP inhibition and induction, permeability (e.g., Caco-2, MDCK, PAMPA), plasma protein and tissue binding, and transporter and other mechanistic assays.
  • Ensure robust support for both small-molecule and large-molecule modalities, adapting methods for new modalities and platforms as the portfolio evolves.
  • Own and maintain fit-for-purpose validation, QC, and SOP frameworks, including root-cause analysis and corrective actions for assay or system deviations.
• Laboratory Automation, Robotics & Miniaturization:
  • Provide scientific and strategic leadership for laboratory automation and robotics within the in vitro ADME space, in close alignment with the Head of Drug Discovery Lab Automation and Transformation.
  • Lead assay miniaturization up to 1536-well formats, from feasibility and optimization through technology transfer into robust, routine operation.
  • Oversee integration of liquid handlers, plate handlers, robotic arms, incubators, readers, and scheduling software into end-to-end automated workflows.
  • Partner with internal automation/engineering and informatics teams to ensure seamless connectivity between instruments, LIMS/ELN, data pipelines, and analytical platforms.
• Cross-Functional Collaboration:
  • Serve as the primary ADME service leader interfacing with DMPK, medicinal chemistry, biology, pharmacology, translational sciences, and data science.
  • Translate portfolio and project needs into clear ADME assay strategies, capacity plans, and timelines; communicate priorities, risks, and trade-offs with transparency at project and governance levels.
  • Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities.
• Quality, Compliance & Continuous Improvement:
  • Ensure scientific quality, data integrity, and safety in all ADME operations, consistent with Takeda policies and relevant regulatory expectations.
  • Define and monitor KPIs for throughput, on-time delivery, reproducibility, and cost; apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement.
  • Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues.
• Education and Experience:
  • Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10+ years of relevant industry experience; or MS with 16+ years; or BS with 18+ years in pharmaceutical/biotech R&D.
  • Extensive expertise in in vitro ADME, including method development, validation, and deployment across core assay types.
  • Direct experience in an organization providing ADME services (e.g., CRO or internal ADME service group), with a strong service- and customer-oriented mindset.
  • Proven leadership experience at the Director level, managing scientific teams and complex operations in a high-throughput environment.
  • Demonstrated strategic and hands-on experience with laboratory automation and robotics, including selection, implementation, and lifecycle management.
  • Successful track record in miniaturizing ADME assays formats, including optimization for data quality, robustness, and throughput.
  • Experience supporting both small- and large-molecule discovery programs.
  • Familiarity with LIMS/ELN, instrument integration, and data analysis/visualization tools in a high-throughput setting.

Qualifications

• Ph.D. or equivalent in a relevant scientific field with 10+ years of industry experience, or MS with 16+ years, or BS with 18+ years in pharmaceutical/biotech R&D.
• Extensive expertise in in vitro ADME, including method development, validation, and deployment across core assay types.
• Direct experience delivering ADME services in a lab or CRO setting with a service-oriented mindset.
• Proven leadership at the Director level, managing scientific teams and high-throughput operations.
• Experience with laboratory automation/robotics, assay miniaturization, and data infrastructure integration (LIMS/ELN).
• Experience supporting both small- and large-molecule discovery programs.

Education

• Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field (or MS/BS with extended industry experience).