Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

GSK; Greater London; On-site; USD 164,000 - 218,000; Full time

Job summary

GSK invites applications for a Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation. Based initially at Stevenage with plans to relocate to Cambridge, the role supports CPMS to accelerate oncology programs and ensure optimal dosing decisions.

You will lead model-based development strategies, conduct exposure–response analyses, and apply AI/ML methods to improve trial design and regulatory submissions. Collaboration across matrix teams is expected.

Qualifications

• PhD in quantitative pharmacology or PharmD/MSc with relevant experience.
• Experience applying AI/ML in clinical pharmacology and modelling.
• Proficiency with pharmacometric tools and regulatory standards.

Responsibilities

• Define and execute model-based development strategies for oncology projects.
• Plan and execute exposure–response analyses and dose selection studies.
• Apply AI/ML and quantitative systems pharmacology to improve trial design and data use.
• Present modeling outcomes to governance boards and regulatory agencies.
• Collaborate across matrix teams and external partners to advance programs.

Education

PhD in Quantitative Pharmacology

PharmD or MSc with 4+ years

Tools

NONMEM

R

Job description

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

We have an exciting opportunity at GSK for a highly motivated and experienced Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. This role focuses on delivering CPMS quantitative excellence to development programs, helping to inform and accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time. GSK provides a supportive environment for scientists who are aspiring to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.

GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and innovation in AI/ML.

As a Director, CPMS Oncology, you will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on small molecules, biologics, and antibody drug conjugates in the Oncology therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.

This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, these responsibilities include some of the following:

• Defining and executing model-based development strategies for oncology projects
• Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling
• Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency
• Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
• Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
• Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
• Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
• Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
• Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
• Work across matrix teams to innovate in methodologies, design efficiencies and create value

Why you?

Basic Qualifications:

• A PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics) or relevant Life Sciences discipline, and experience in using modelling/simulation to solve practical problems in industry or academia. A PharmD or Master degree in the same disciplines with an additional 4 years of relevant experience may be considered.
• 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM or R
• 3+ years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards
• Expertise in applications of AI/ML in Clinical Pharmacology and Pharmacometric analyses with innovative methodologies and efficiency applications.

Preferred Qualifications:

• Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design
• Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancers
• Ability to keep up-to-date with and propose the implementation of new modeling approaches to inform drug development.
• Demonstrated aptitude for productive collaboration