Director,Head of Biopharmaceutics Predictive Modeling - Oral Drug Product Job Boston area,Massachusetts USA,Pharmaceutical

Job Description
ACCOUNTABILITIES

Provides strategic and operational leadership for the Biopharmaceutics Predictive Modeling function, with a focus on mechanistic biopharmaceutics, PBPK/PBBM, and model-informed drug development to support oral drug product development and portfolio objectives.
Builds and develops a high-performing team of biopharmaceutics and modeling scientists who work across the Oral Drug Product organization to integrate mechanistic understanding, computational modeling, and experimental data into development strategies.
Leads the development and implementation of biopharmaceutics and predictive modeling strategies to inform API and formulation selection, oral dosage form design, dissolution performance, dose selection, and clinical development decisions across the product lifecycle.
Directs the application of physiologically based pharmacokinetic (PBPK), physiologically based biopharmaceutics modeling (PBBM), mechanistic absorption modeling, and dissolution–absorption modeling to predict drug product performance, systemic exposure, and clinical pharmacokinetic outcomes.
Oversees the integration of API physicochemical properties, solubility, permeability, dissolution, precipitation, supersaturation, gastrointestinal physiology, and formulation characteristics to understand and predict the impact of drug product attributes on absorption and bioavailability.
Provides scientific and organizational leadership in model-informed drug development, including PBPK/PBBM, mechanistic oral absorption, food-effect prediction, relative bioavailability, exposure prediction, in vitro–in vivo correlation (IVIVC), and in vitro–in vivo relationship (IVIVR) development.
Works closely with the formulation scientists and project teams to evaluate formulation and process changes, support clinical bridging, assess biopharmaceutics risk, and inform decisions related to formulation selection, dose and dosage form optimization, and product lifecycle management.
Partners with key CMC stakeholders (formulation development, analytical sciences, clinical pharmacology, drug metabolism and pharmacokinetics (DMPK), regulatory) to integrate modeling and biopharmaceutics assessments into development plans and program decisions.
Directs the preparation and scientific justification of biopharmaceutics and modeling contributions to regulatory submissions and health authority interactions, including model qualification, verification, sensitivity analysis, uncertainty assessment, and model credibility.
Establishes functional strategy, scientific standards, best practices, and governance for biopharmaceutics modeling and simulation across oral drug product development, ensuring fit-for-purpose model application and appropriate integration of experimental and clinical evidence.
Builds organizational capability through training, talent development, resource planning, external partnerships, and continuous advancement of mechanistic modeling and biopharmaceutics capabilities.
Drives innovation in predictive biopharmaceutics to improve the probability of clinical success, reduce development uncertainty, accelerate formulation and clinical decisions, and enable more efficient development of oral drug products.

DIMENSIONS AND ASPECTS

Deep expertise in oral biopharmaceutics, pharmaceutical development, mechanistic absorption, PBPK/PBBM, and model-informed drug development, with a demonstrated record of applying these approaches to pharmaceutical development decisions.
Strong understanding of the relationship between API physicochemical properties, formulation design, dissolution and solubilization, gastrointestinal physiology, absorption, and systemic exposure.
Demonstrated expertise in developing, applying, interpreting, and…

Director, Head of Biopharmaceutics Predictive Modeling - Oral Drug Product