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About the Role

This role focuses on delivering 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.

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
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

Requirements

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.
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

Skills

Drug Design
Drug Development
Drug Discovery Process
Drug Discovery Research
Medication Safety
Molecular Modeling
Pharmaceutical Regulatory Compliance
Pharmaceutical Sciences
Pharmacodynamics
Pharmacokinetics
Pharmacology
Pharmacometrics
Pharmacovigilance
Study Design
Target Validation
NONMEM
R

Location

Stevenage, UK
Cambridge, UK

Work Type

Hybrid

Experience Level

Director

Education Level

PhD
PharmD
Master degree

Salary/Compensations

US: $188,100 to $313,500
Belgium: EUR 119,250 to EUR 198,750

Benefits

Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Annual bonus
Eligibility to participate in share based long term incentive program

About the Company

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.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Equal Opportunity

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.