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 for RIIRU, serving as an advanced technical SME. It integrates modeling approaches with disease-level data and novel digital and imaging endpoints to inform asset and mechanism-level decision-making, optimizing dosing, trial design, regulatory strategy, and go/no-go decisions. The Lead advocates for regulatory MIDD strategies and collaborates across AI/ML, CPMS, QSP, digital, imaging, biomarker, biostatistics, clinical, translation sciences, and epidemiology teams to accelerate programs.

Responsibilities

• Design & Execute MIDD Strategies: Drive optimal use of MIDD approaches, data plans, and model evaluation to inform disease-, program-, and business-level decisions; develop and implement robust evidence strategies within RIIRU; advance MIDD Evidence frameworks and documentation standards to de-risk and accelerate programs; optimize internal and regulatory strategies to deliver transformative therapies.
• Technical Expertise: Act as a subject matter expert for modeling and simulation for a (sub)-therapeutic area; lead development of challenging M&S plans, analyses, and reports; contribute to regulatory interactions involving quantitative evidence with clear communication of modeling assumptions.
• Optimize & Innovate: Promote current M&S methodologies (e.g., MBMA, disease progression modeling) and integrate with AI/ML and SciML; develop practices, training, and 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, or related quantitative disciplines (QSP).
• Required: Deep expertise and demonstrated application of M&S methods and software used in MIDD (e.g., population PK/PD, exposure–response, MBMA, disease progression modeling) with proven impact on clinical development and regulatory decision making.
• Required: Advanced understanding of regulatory and ICH guidelines across major markets related to clinical study design and drug development strategy with emphasis on MIDD.
• Required: Ability to rapidly attain therapeutic area literacy and communicate MIDD strategy to clinical experts; strong collaboration and accountability for timely delivery of results; ability to prioritize multiple tasks in complex environments.
• Preferred: Strong knowledge of MIDD in RIIRU-relevant disease areas with hepatology knowledge as an additional advantage.
• Preferred: Hands-on experience with AI/ML applications to MIDD M&S methods; hands-on PBPK and/or QSP skills.

Education

• Advanced degree (PhD or PharmD) in pharmacometrics, clinical pharmacology, physiological PK/PD modeling, or related quantitative discipline; postdoctoral experience preferred.