Strategic Leader: Predictive Modeling & 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

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.