Director, Oncology Clinical Pharmacology Midd Ai/Ml in Stevenage

Director, Oncology Clinical Pharmacology MIDD AI/ML

This position requires an on‑site office presence for 2–3 days per week.

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. The 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 an impact on business decisions through innovation, expertise and influence.

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.

Responsibilities

• 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 modelling, 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
• Writing or reviewing clinical pharmacology components of regulatory documents and responses so that GSK products are rapidly and efficiently approved with optimum labelling (with regard to the clinical pharmacology, modelling and simulation contents)
• Implementing best practices, trends and lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to the R&D pipeline
• Interacting 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
• Working across matrix teams to innovate in methodologies, design efficiencies and create value

Basic Qualifications

• A PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics) or a relevant Life Sciences discipline, with experience in using modelling/simulation to solve practical problems in industry or academia. A PharmD or Master’s 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 modelling approaches to inform drug development
• Demonstrated aptitude for productive collaboration in a multi‑discipline team, using effective communication and taking personal accountability for timely delivery of results
• Clear evidence of ability to make sound judgment in complex situations and adapt to changing business needs by prioritizing multiple tasks
• Experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards
• Passion for quantitative clinical pharmacology and desire to innovate for better outcomes
• Prior experience in oncology research and development is a plus
• Experience working with senior stakeholders in a cross‑functional environment
• Excellent interpersonal skills with strong oral and written communication and presentation skills
• Strong track record of implementation of model‑informed drug development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs

Compensation & Benefits

Salary ranges and benefits will be discussed during the recruitment process.

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.