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

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:

We are looking for professionals with these required skills to achieve our goals:

• 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:

If you have the following characteristics, it would be a plus:

• 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 in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results
• Clear evidence of ability to make sound judgement 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 outcome
• 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/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