Director, Oncology Clinical Pharmacology Modeling and Simulation

GSK•Durham, NC

1d•Hybrid

About The Position

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. 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 position requires an on-site office presence for 2-3 days per week.

Requirements

PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia. 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 model-based analysis of clinical data per industry and regulatory standards.

Nice To Haves

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
Experience with AI/ML tools and applications in pharmacometrics
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 Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs.

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 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