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. The 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, clinical trial design, regulatory strategy, and go/no-go decisions, with emphasis on disease-level data and novel digital and imaging endpoints to inform asset and mechanism-level decision-making.

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, advancing MIDD Evidence frameworks and documentation standards to de-risk and accelerate programs, optimizing internal and regulatory strategies to deliver transformative therapies.
• Technical Expertise: Act as a subject matter expert for modeling and simulation (M&S) for a (sub)-therapeutic area, leading development of technically challenging M&S plans, analyses, and reports. Contribute to regulatory interactions involving quantitative evidence, ensuring clear communication of modeling assumptions and alignment with decision-making impact.
• Optimize & Innovate: Promote effective use of current M&S methodologies (e.g., MBMA, disease progression modeling) and integrate with emerging technologies (AI/ML, SciML). Develop good 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, conferences, and contributions to scientific and regulatory communities 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 modeling or related quantitative disciplines (QSP).
• Required: Deep understanding and demonstrable application of M&S methods and software used in MIDD (e.g., population PK/PD, exposure–response, MBMA, disease progression modeling) and their effective use in clinical development and regulatory decision making.
• Required: Advanced understanding of regulatory and ICH guidelines across major markets related to design of clinical studies and drug development strategy with emphasis on MIDD.
• Required: Ability to rapidly attain therapeutic area literacy to implement and communicate the MIDD strategy to clinical experts; demonstrated collaboration in multi-disciplinary teams and accountability for timely delivery; ability to prioritize multiple tasks in complex, changing environments.
• Preferred: Strong knowledge of MIDD in RIIRU-relevant disease areas; hepatology knowledge a plus.
• Preferred: Hands-on use of AI/ML and application to MIDD M&S methods.
• Preferred: Hands-on PBPK and/or QSP skills.