Role Summary
The Director, High-Throughput In Vitro ADME is a senior scientific and operational leader responsible for building and directing TakedaβΓΓ΄s high-throughput in vitro ADME capabilities in support of small- and large-molecule discovery programs. This 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.
Responsibilities
- Strategic Leadership & Vision: Define and execute the multi-year strategic roadmap for high-throughput in vitro ADME at Takeda; shape an enterprise-level, service-oriented operating model; champion innovation in 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; build a culture of scientific rigor, operational excellence, safety, and customer focus with clear KPIs; drive talent development and performance management 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 metabolic stability/clearance, CYP inhibition/induction, permeability, plasma protein/tissue binding, transporter and other mechanistic assays; ensure robust support for small- and large-molecule modalities; maintain validation, QC, and SOP frameworks with root-cause analysis and corrective actions for deviations.
- Laboratory Automation, Robotics & Miniaturization: Provide leadership for automation and robotics; lead assay miniaturization up to 1536-well formats; oversee integration of liquid handlers, plate handlers, robotic arms, incubators, readers, and software; collaborate with automation/engineering and informatics teams for seamless connectivity between instruments, LIMS/ELN, data pipelines, and analytical platforms.
- Cross-Functional Collaboration: Interface with DMPK, medicinal chemistry, biology, pharmacology, translational sciences, and data science; translate portfolio needs into ADME assay strategies and timelines; communicate priorities and risks; collaborate with external CROs and vendors when appropriate.
- Quality, Compliance & Continuous Improvement: Ensure scientific quality, data integrity, and safety; define and monitor KPIs for throughput, on-time delivery, reproducibility, and cost; apply Lean, Six Sigma, and DoE; oversee investigations and CAPA related to assay performance, automation reliability, or data issues.
- Education and Experience: Leverage Ph.D. in Pharmaceutical Sciences/Drug Metabolism/Biochemistry/Pharmacology (10+ years) or MS with 16+ years or BS with 18+ years in pharmaceutical/biotech R&D; extensive in vitro ADME expertise; experience delivering ADME services; proven Director-level leadership; demonstrated experience with automation/robotics and miniaturization; familiarity with LIMS/ELN and data analysis tools.
Qualifications
- Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related 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 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, optimizing 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.
Skills
- High-throughput assay design and execution
- Laboratory automation, robotics, and miniaturization (up to 1536-well formats)
- ADME method development, validation, and deployment
- Project/portfolio management and strategic planning
- Data analysis, visualization, and interpretation
- Lean, Six Sigma, and design of experiments (DoE) methodologies
- Cross-functional collaboration and vendor/CRO management
Education
- Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field (or equivalent experience).
- Additional certifications in process optimization or related areas are a plus.
Additional Requirements
- The position will be based in Cambridge, MA with hybrid work arrangement.