Director Clinical Pharmacology MIDD Lead

Director Clinical Pharmacology MIDD Lead

Location: UK – Hertfordshire – Stevenage, GSK HQ, Upper Providence, USA – Massachusetts – Waltham, USA – North Carolina – Durham

Posted Date: Dec 16 2025

The Clinical Pharmacology and Quantitative Medicine (CPQM) group at GSK is a newly established organization dedicated to becoming a Centre of Excellence in Model‑Informed Drug Development (MIDD). The MIDD Lead is a scientific and strategic leader who applies modelling and simulation to inform drug development decisions. The MIDD Lead is responsible for leading the development and implementation of MIDD evidence strategies, serving as an advanced technical and subject‑matter expert for a therapeutic or sub‑therapeutic area within the Respiratory, Immunology & Inflammation Research Unit (RIIRU).

This role oversees integration and leads on the delivery of advanced modelling and simulation approaches, building on or extending model‑informed clinical pharmacology strategies, incorporating disease‑level data and novel digital and imaging endpoints to inform asset and mechanism‑level decision‑making. The role integrates advanced pharmacometrics approaches, alongside systems pharmacology, biostatistics, and data science to optimise dosing, clinical trial design, regulatory strategy, and go/no‑go decisions.

The role supports optimisation and promotion of the effective use of established M&S methodologies (including MBMA and disease progression modelling) and the integration of emerging technologies (including AI/ML and SciML). In collaboration with AI/ML lead & experts within the MIDD team, CPMS, QSP, digital, imaging, and biomarker teams within CPQM, and multiple functions across RIIRU and GSK.

Key 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, optimising 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 and rigor in alignment with decision‑making impact.
• Optimize & Innovate:
  Promote effective use of current M&S methodologies (e.g., MBMA, disease progression modelling) 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 modelling 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.

Basic Qualifications:

• Advanced degree (PhD or Pharm
  
  D and post‑doctoral experience preferred) in pharmacometrics, clinical pharmacology, physiological PK/PD, mechanistic modelling or related quantitative disciplines, including QSP.
• A deep understanding and examples of successful application of various M&S methods and software used in MIDD (e.g., population PK/PD, exposure‑response, MBMA and disease progression modelling) with demonstration of their effective use in clinical development and regulatory decision‑making.
• Advanced understanding of relevant 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.
• Ability to quickly attain the therapeutic or sub‑therapeutic…