Director, Head of Predictive Modelling & Biopharmaceutics

Takeda Pharmaceutical Co.; Boston (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

Takeda Pharmaceutical Co. in Boston is seeking a senior leader to guide Predictive Modeling and Biopharmaceutics within drug product development. You will drive modeling excellence across formulation and product performance evaluation, influencing decisions from early design to regulatory submissions.

The role requires strategic oversight of PBPK/PBBM and IVIVC/IVIVR methodologies, with collaboration across formulation, analytical, regulatory, and CMC teams to deliver robust development plans.

Responsibilities

• Provides strategic and operational leadership for Predictive Modeling and Biopharmaceutics within drug product development.
• Builds and develops a high performing predictive modeling and biopharmaceutics team across the Oral Drug Product Development organization.
• Leads development and implementation of predictive modeling and biopharmaceutics strategies to support formulation design and product performance.
• Ensures application of modeling and simulation to assess biopharmaceutics risks, including absorption, dissolution, and bioavailability.
• Oversees generation, interpretation, and integration of biopharmaceutics data for timely development decisions.
• Provides scientific and organizational leadership in PBPK/PBBM, absorption modelling, and IVIVC/IVIVR.
• Partners with cross-functional stakeholders (formulation, analytical, regulatory, and CMC) to embed predictive strategies into program plans.
• Directs contributions of predictive modeling expertise to regulatory strategies and submissions.

Job description

Job Description

ACCOUNTABILITIES:

• Provides strategic and operational leadership for the Predictive Modeling and Biopharmaceutics function within drug product development, ensuring capabilities, priorities, and deliverables align with portfolio and business objectives.
• Builds and develop a high performing predictive modeling and biopharmaceutics team which works across the whole Oral Drug Product Development organization to drive modelling excellence and execution
• Leads the development and implementation of predictive modeling and biopharmaceutics strategies to support formulation design, dosage form selection, and product performance evaluation across development stages.
• Ensures the effective application of modeling and simulation approaches to assess biopharmaceutics risks, including absorption, dissolution, bioavailability, and in vivo performance.
• Oversees the generation, interpretation, and integration of biopharmaceutics data to enable scientifically sound and timely development decisions.
• Provides scientific and organizational leadership in predictive sciences, including PBPK/PBBM, absorption modelling, IVIVC/IVIVR, and related methodologies, to strengthen development outcomes and decision quality.
• Partners with cross-functional stakeholders across formulation, analytical, clinical pharmacology, regulatory, and CMC disciplines to incorporate predictive and biopharmaceutics strategies into program plans.
• Directs the contribution of predictive modeling and biopharmaceutics expertise to regulatory strategies and submissions, ensuring scientific rigor and alignment with applicable regulatory