Director, Head of Predictive Modeling & Biopharmaceutics

Job Description

ACCOUNTABILITIES:

• Provides strategic and operational leadership for the Predictive Modeling and Biopharmaceutics function within drug product development, ensuring capabilities, priorities, and deliverables align with portfolio and business objectives.
• Builds and develop a high performing predictive modeling 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 modeling and biopharmaceutics strategies to support formulation design, dosage form selection, and product performance evaluation across development stages.
• Ensures the effective application of modeling 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 modeling 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.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

Deepexpertisein pharmaceutical development, predictive modelling and biopharmaceutics. Proven track record of successful application of mechanistic and PPBMmodelling in drug development.

Abilityto workin aglobalecosystem(internalandexternal) with a high degree ofcomplexityandaddressthe challenge withenterpriselevelperspective. Abilityto lead/coordinate pipelineprogramand cross-functionalinitiativebymutuallyaligningdifferentconstraintsandprioritieswithrelevantstakeholder

Leadership

Hiresand mentorsa group of predictive modeling scientists and engineers toexecute Pharmaceutical Sciences in silico Modeling strategy for the oral drug product development department (ODPD).Influences direction through recognizedexpertiseand strong cross-functional partnerships. Mobilizes and leads high-performing, cross-functional teams across multiple programs; drivingalignmentand disciplined execution. Champions change and inclusive leadership; develops the immediate team through coaching, mentoring, feedback, and deliberate skill building.

Decision-making and Autonomy

Operates with high autonomy and accountability to execute portfolio/program approaches, scientific plans, resourcing proposals, and partner models within agreed governance. Makes complex, risk-based decisions (or recommendations) on development approach, critical-path trade-offs, and mitigation actions across scope, budget, timeline, and quality; escalates appropriately and ensures decisions are documented and communicated. Anticipates program and capability needs and initiates actions to close gaps with minimal oversight.

Interaction

Primary internal partners include other ODPD function heads and department members, other Pharmaceutical Sciences department stakeholders in AD and SMPD, Clinical Pharmacology and Drug metabolism (DMPK) Leads/Managers;
Global Regulatory; quality; procurement/supplier management; and clinical biomarker development functions. Leads external technical interactions with consultants and development partners; supports contracting and governance interactions in partnership with legal and procurement.

Innovation

Explores and evaluates emerging predictive modeling and biopharmaceutics technologies; proposes creative solutions to meet stakeholder needs and program constraints. Shares knowledge across the organization through technical reviews, best practices,…