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. They lead the development and implementation of MIDD evidence strategies for RIIRU, serving as an advanced technical subject matter expert for a therapeutic area within RIIRU. The role integrates pharmacometrics, systems pharmacology, biostatistics, and data science to optimize dosing, clinical trial design, regulatory strategy, and go/no-go decisions, with the aim of de-risking and accelerating programs. The position is based in the UK or US, with remote working or placement at other European GSK sites possible for the right candidate.

Responsibilities

• Design & Execute MIDD Strategies: Drive optimal use of MIDD approaches, associated 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 modelling and simulation (M&S) for a (sub)-therapeutic area serving as a contributor and technical coach. Lead development of the more technically challenging M&S plans, analyses, and reports. Contribute to regulatory interactions involving quantitative evidence, ensuring clear communication of modelling assumptions, rigor in alignment with the impact on decision-making.
• 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 strong 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 examples of successful application of modelling and simulation methods and software used in MIDD (e.g., population PK/PD, exposure-response, MBMA, disease progression modeling), and demonstration of their effective use in clinical development and regulatory decision making.
• Required: Advanced understanding of regulatory and ICH guidelines across major markets related to the design of clinical studies and drug development strategy, with particular emphasis on the role of MIDD.
• Required: Ability to quickly attain the therapeutic or sub-therapeutic area literacy sufficient to implement and communicate the MIDD strategy to clinical experts.
• Required: Demonstrated aptitude for productive collaboration in a multi-disciplinary team, using effective communication and taking personal accountability for timely delivery of results.
• Required: Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.
• Preferred: Strong knowledge of applying MIDD in RIIRU-relevant disease areas, with hepatology knowledge an additional advantage.
• Preferred: Hands-on use of AI/ML and application to MIDD M&S methods.
• Preferred: Hands-on PBPK and/or QSP skills.