Director, Head of Biopharmaceutics Predictive Modeling Oral Drug Product

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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 dissolutionabsorption 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 vitroin vivo correlation (IVIVC) and in vitroin 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 evaluating mechanistic models to predict oral drug product performance and clinical pharmacokinetics including scenarios involving poorly soluble compounds modified-release drug products food effects and formulation changes.

Ability to integrate in vitro dissolution and biopharmaceutics data preclinical and clinical pharmacokinetics and mechanistic model outputs to inform formulation strategy clinical study design and regulatory decisions.

Proven ability to lead programs and cross-functional initiatives within a complex global development organization aligning scientific priorities resources timelines and portfolio objectives.

Leadership

Hires develops trains and mentors a high-performing team of biopharmaceutics predictive modeling scientists responsible for advancing the Pharmaceutical Sciences in silico modeling strategy for Oral Drug Product Development.

Establishes a clear functional vision centered on mechanistic biopharmaceutics PBPK/PBBM oral absorption and prediction of clinical drug product performance.

Influences scientific and development strategy through recognized expertise effective cross-functional partnerships and the ability to translate complex modeling outputs into actionable development recommendations.

Mobilizes and leads cross-functional teams across multiple programs driving alignment accountability scientific rigor and disciplined execution.

Champions inclusive leadership talent development succession planning and continuous capability building.

Decision-Making and Autonomy

Operates with high autonomy and accountability in defining modeling strategies scientific plans resource requirements and external partnerships within established governance.

Makes and communicates risk-based recommendations on formulation selection biopharmaceutics risk clinical bridging food-effect assessment dose and dosage form optimization and development strategy.

Uses model-informed assessments to evaluate competing development options identify critical uncertainties prioritize experiments and guide decisions affecting scope budget timeline and product quality.

Establishes appropriate standards for model applicability verification qualification sensitivity analysis and uncertainty assessment ensuring that conclusions are proportionate to the available evidence and intended regulatory use.

Interaction

Partners with Oral Drug Product function heads and teams Pharmaceutical Sciences analytical development clinical pharmacology DMPK regulatory affairs quality and other CMC stakeholders to develop integrated model-informed strategies.

Works closely with clinical pharmacology and DMPK teams to integrate preclinical and clinical PK data characterize absorption and exposure and refine mechanistic predictions.

Leads technical interactions with external modeling experts consultants software providers academic groups and development partners.

Supports external collaborations and contracting in partnership with procurement legal and relevant governance functions.

Innovation

Evaluates and implements emerging PBPK/PBBM methods mechanistic absorption approaches and model-informed development strategies relevant to oral drug products.

Advances the use of predictive biopharmaceutics to support early formulation selection reduce unnecessary experimentation optimize clinical study design and improve development efficiency.

Promotes integration of experimental preclinical clinical and modeling evidence to address complex development questions and improve the quality of scientific decisions.

Shares knowledge and best practices across the organization through technical reviews case studies mentoring and cross-functional scientific forums.

Complexity

Leads a global multidisciplinary function addressing complex and interdependent challenges in oral drug absorption formulation performance clinical pharmacokinetics and drug product development.

Integrates diverse datasets and scientific disciplines to address variability in solubility dissolution precipitation gastrointestinal transit permeability food effects and systemic exposure.

Navigates complex development and regulatory environments applying mechanistic modeling appropriately across discovery preclinical clinical registration and lifecycle stages.

Balances scientific uncertainty model limitations experimental requirements clinical risk regulatory expectations and portfolio priorities to support timely evidence-based decisions.

EDUCATION BEHAVIORAL COMPETENCIES AND SKILLS

PhD in Pharmaceutics Pharmaceutical Sciences Biopharmaceutics Pharmaceutical Engineering Pharmacokinetics or a related scientific discipline with 810 years of relevant industry experience; alternatively a masters degree with 1014 years or a bachelors degree with 1518 years of relevant experience.

Extensive pharmaceutical or biopharmaceutical industry experience including progressive leadership responsibility in oral drug product development biopharmaceutics modeling and simulation and CMC strategy.

Demonstrated expertise in PBPK/PBBM and mechanistic oral absorption modeling including application to formulation development dissolution and solubilization bioavailability food effects exposure prediction and model-informed drug development.

Strong understanding of oral biopharmaceutics including API solubility and permeability dissolution precipitation supersaturation gastrointestinal physiology absorption mechanisms and the influence of formulation and dosage form characteristics on clinical performance.

Proven experience integrating in vitro dissolution and biopharmaceutics data with preclinical and clinical pharmacokinetic data to develop refine and apply mechanistic models for development decision-making.

Experience applying IVIVC/IVIVR and related approaches to evaluate formulation performance support clinical bridging assess formulation or manufacturing changes and establish relationships between in vitro performance and in vivo exposure.

Experience supporting regulatory submissions and health authority interactions including the preparation and defense of model-informed biopharmaceutics assessments and scientific justifications.

Demonstrated understanding of model development verification qualification sensitivity analysis uncertainty assessment and model credibility with the ability to determine when modeling is appropriate to support a particular development or regulatory decision.

Proven ability to lead and develop high-performing scientific teams including talent development coaching succession planning and functional capability building.

Strong cross-functional leadership and collaboration skills with the ability to influence formulation analytical clinical pharmacology DMPK regulatory and CMC stakeholders.

Excellent communication and strategic thinking skills including the ability to translate complex mechanistic modeling results into clear actionable recommendations for senior leaders project teams and regulatory audiences.

Demonstrated leadership sound scientific judgment innovation and decision-making capabilities with the ability to balance scientific rigor business priorities development risk and portfolio needs.

High learning agility adaptability and commitment to continuous improvement with the ability to build organizational capability and foster collaboration accountability and inclusion.

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