Director, Head of Biopharmaceutics Predictive Modeling - Oral Drug Product

• Builds organizational capability through training, talent development, resource planning, external partnerships, and continuous advancement of mechanistic modeling and biopharmaceutics capabilities.
• Strong understanding of the relationship between API physicochemical properties, formulation design, dissolution and solubilization, gastrointestinal physiology, absorption, and systemic exposure.
• Proven ability to lead programs and cross-functional initiatives within a complex global development organization, aligning scientific priorities, resources, timelines, and portfolio objectives.
• 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.
• 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.
• 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.
• 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.
• Extensive pharmaceutical or biopharmaceutical industry experience, including progressive leadership responsibility in oral drug product development, biopharmaceutics modeling and simulation, and CMC strategy.
• 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.

None flagged.