Director, Head of Biopharmaceutics Predictive Modeling - Oral Drug Product

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T

takeda.com

10,001+ employees

Pharmaceutical Manufacturing

Tokyo

1781

Public Company

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Raised $2.5B

• 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.
• 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.
• 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.
• biopharmaceutics predictive modeling scientists responsible for advancing the
• Pharmaceutical Sciences in silico modeling strategy for Oral Drug Product
• Development.
• 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.
• 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.
• 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.
• 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.
• procurement, legal, and relevant governance functions.
• 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.
• 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.
• 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.

• PhD in Pharmaceutics, Pharmaceutical Sciences, Biopharmaceutics,
• Pharmaceutical Engineering, Pharmacokinetics, or a related scientific
• discipline, with 8–10+ years of relevant industry experience; alternatively, a
• master’s degree with 10–14+ years or a bachelor’s degree with 15–18+ 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.
• 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.
• 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.

• We understand compensation is an important factor as you consider the next step
• in your career. We are committed to equitable pay for all employees, and we
• strive to be more transparent with our pay practices.
• $177,000.00 - $278,080.00
• The estimated salary range reflects an anticipated range for this position. The
• actual base salary offered may depend on a variety of factors, including the
• qualifications of the individual applicant for the position, years of relevant
• experience, specific and unique skills, level of education attained,
• certifications or other professional licenses held, and the location in which
• the applicant lives and/or from which they will be performing the job. The
• actual base salary offered will be in accordance with state or local minimum
• wage requirements for the job location.