Director, Oncology Clinical Pharmacology, Modeling and Simulation

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, ensuring innovative oncology therapies reach patients at the right time, dose, and place. You will work on small molecules, biologics, and antibody drug conjugates in the oncology therapeutic area, beginning 6 months prior to FTIH through 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, 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 outcomes 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 to accelerate GSK product approvals.
• Implementing best practices, trends, and lessons learned from internal and external sources to advance R&D pipeline.
• Interacting with line and middle management, staff, and external contacts at functional, strategic, and tactical levels.
• Promoting model‑informed drug discovery and development through external collaboration, journal publication, and conference presentation.
• Working across matrix teams to innovate 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 solving industry or academic problems using modelling/simulation. A PharmD or Master’s degree with an additional 4 years of relevant experience may be considered.
• 5+ years of experience in mechanistic PKPD and longitudinal disease modelling; proficiency in NONMEM or R.
• 3+ years of experience planning, performing, and reporting analysis of clinical data per industry and regulatory standards.
• Expertise in applying AI/ML to clinical pharmacology and pharmacometric analyses with innovative methodologies.

Preferred Qualifications

• Strong drive and learning agility to build knowledge on drug‑disease systems, symptom progression, standard of care, and trial design.
• Knowledge of or ability to quickly learn the mechanisms, endpoints, progression, and treatments of cancers.
• Capability to keep up‑to‑date with and propose new modelling approaches to inform drug development.
• Demonstrated aptitude for productive collaboration in multi‑disciplinary teams, effective communication, and timely delivery of results.
• Clear evidence of sound judgment in complex situations and ability to prioritize multiple tasks amid changing business needs.
• Experience in designing, analyzing, interpreting, and reporting clinical pharmacology studies per industry and regulatory standards.
• Passion for quantitative clinical pharmacology and a desire to innovate for better outcomes.
• Prior oncology R&D experience is a plus.
• Experience working with senior stakeholders in a cross‑functional environment.
• Excellent interpersonal skills with strong oral, written, and presentation abilities.
• Strong track record of implementing model‑informed drug development (MIDD) approaches to accelerate patient access and expand therapeutic indications of marketed drugs.

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 (including family medical history), military service, or any basis prohibited under federal, state, or local law.