Director Clinical Pharmacology MIDD Lead

Role Summary

The MIDD Lead is a scientific and strategic leader who applies modelling and simulation to inform drug development decisions. This role leads the development and implementation of MIDD evidence strategies, serving as an advanced technical and subject matter expert for a therapeutic or subtherapeutic area within RIIRU. It integrates advanced pharmacometrics approaches with systems pharmacology, biostatistics, and data science to optimize dosing, trial design, regulatory strategy, and go/no-go decisions, and promotes the use of MBMA, disease progression modelling, AI/ML and SciML to accelerate programs and support regulatory decisions.

Responsibilities

• Design & Execute MIDD Strategies: Drive optimal use of MIDD approaches, data plans, and model evaluation strategies to inform disease-, program-, and business-level decisions; develop and implement robust evidence strategies within RIIRU to accelerate programs and optimize internal and regulatory strategies.
• Technical Expertise: Act as a subject matter expert for modeling and simulation (M&S) for a (sub)-therapeutic area; lead development of technically challenging M&S plans, analyses, and reports; contribute to regulatory interactions with clear communication of modeling assumptions and impacts on decision-making.
• Optimize & Innovate: Promote current M&S methodologies (e.g., MBMA, disease progression modeling) and integrate with emerging technologies (AI/ML, SciML); develop best practices, training, and wider adoption strategies.
• Shape Future Methods: Collaborate with global CPMS, academic partners, and external experts to develop scalable methodologies aligned with RIIRU needs.
• Cross-Functional Partnerships: Build networks across AI/ML, CPMS, QSP, biomarkers, digital, imaging, biostatistics, clinical, and real-world data teams to embed advanced modeling into decision-making frameworks.
• External Engagement: Enhance external profile through publications and conferences in MIDD, pharmacometrics, QSP, and AI/ML integration.

Qualifications

• Required: Advanced degree (PhD or PharmD; postdoctoral experience preferred) in pharmacometrics, clinical pharmacology, physiological PK/PD modelling, or related quantitative disciplines (QSP). Demonstrated successful application of M&S methods (e.g., population PK/PD, exposure–response, MBMA, disease progression modeling) and their effective use in clinical development and regulatory decision-making.
• Advanced understanding of regulatory and ICH guidelines across major markets related to clinical study design and drug development, with emphasis on the role of MIDD.
• Ability to quickly attain therapeutic area literacy and communicate MIDD strategy to clinical experts.
• Demonstrated collaboration in a multi-disciplinary team, strong communication, and accountability for timely delivery of results.
• Ability to make sound judgments in complex situations and adapt to changing business needs by prioritizing multiple tasks.

Preferred Qualifications

• Preferred: Strong knowledge and experience applying MIDD in RIIRU-relevant disease areas; hepatology knowledge is a plus.
• Hands-on experience with AI/ML applications to MIDD M&S methods.
• Hands-on PBPK and/or QSP skills.