Director, Head of Predictive Modelling & Biopharmaceutics

Takeda•Boston, MA

9d•Onsite

About The Position

Provides strategic and operational leadership for the Predictive Modelling and Biopharmaceutics function within drug product development, ensuring capabilities, priorities, and deliverables align with portfolio and business objectives. Builds and develops a high-performing predictive modelling 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 modelling and biopharmaceutics strategies to support formulation design, dosage form selection, and product performance evaluation across development stages. Ensures the effective application of modelling 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 modelling and biopharmaceutics expertise to regulatory strategies and submissions, ensuring scientific rigor and alignment with applicable regulatory expectations. Builds and maintains organizational capability through talent development, resource planning, and leadership of a high-performing scientific team. Establishes standards, processes, and best practices for the use of predictive modelling and biopharmaceutics approaches within drug product development. Drives innovation and continuous improvement in predictive sciences to enhance efficiency, reduce development risk, and support successful product advancement.

Requirements

PhD in Chemistry, Pharmaceutics, Mathematics, Statistics, Engineering or related pharmaceutical science and 8-10+ years relevant industry experience
Master’s degree in Chemistry, Pharmacy, Mathematics, Statistics, Engineering or related pharmaceutical science and 10-14+ years relevant industry experience
Bachelor’s degree in Chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15-18+ years relevant industry experience.
Extensive pharmaceutical or biopharmaceutical industry experience required, including progressive leadership responsibility in drug product development, biopharmaceutics, modelling and simulation, and CMC strategy for oral dosage forms.
Demonstrated expertise in predictive modelling approaches such as PBPK/PBBM, mechanistic absorption modelling, dissolution modelling, IVIVC/IVIVR, and model-informed drug development to support oral formulation design and clinical performance prediction.
Strong scientific knowledge of oral biopharmaceutics and drug product development is required, including absorption, bioavailability, dissolution, food effect, formulation performance, and phase-appropriate development of oral dosage forms.
Experience supporting regulatory submissions and health authority interactions is required, with the ability to provide scientifically robust modelling and biopharmaceutics justifications for formulation strategy, clinical bridging, and product changes.
Proven ability to lead and develop high-performing scientific teams, including talent development, coaching, succession planning, and establishment of functional capabilities aligned with business and portfolio needs.
Strong cross-functional leadership and collaboration skills with the ability to influence across formulation, analytical, clinical pharmacology, regulatory, quality, and CMC teams to drive aligned decisions and integrated development strategies.
Excellent communication and strategic thinking skills with the ability to translate complex modelling and biopharmaceutics concepts into clear recommendations for senior leaders, project teams, and regulatory audiences.
Demonstrated behavioral competencies in leadership, sound judgment, innovation, and decision making, with a strong ability to balance scientific rigor, business priorities, and development risk in a dynamic environment.
High learning agility, adaptability, and commitment to continuous improvement are required, along with the ability to build organizational capability, advance new scientific approaches, and foster a culture of collaboration, accountability, and inclusion.

Responsibilities

Provides strategic and operational leadership for the Predictive Modelling and Biopharmaceutics function within drug product development, ensuring capabilities, priorities, and deliverables align with portfolio and business objectives.
Builds and develops a high-performing predictive modelling 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 modelling and biopharmaceutics strategies to support formulation design, dosage form selection, and product performance evaluation across development stages.
Ensures the effective application of modelling 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 modelling and biopharmaceutics expertise to regulatory strategies and submissions, ensuring scientific rigor and alignment with applicable regulatory expectations.
Builds and maintains organizational capability through talent development, resource planning, and leadership of a high-performing scientific team.
Establishes standards, processes, and best practices for the use of predictive modelling and biopharmaceutics approaches within drug product development.
Drives innovation and continuous improvement in predictive sciences to enhance efficiency, reduce development risk, and support successful product advancement.