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GlaxoSmithKline

Director, Clinical Pharmacology Modelling and Simulation

GlaxoSmithKline, Waltham, Massachusetts, United States, 02254


Site Name:

UK - Hertfordshire - Stevenage, USA - Massachusetts - WalthamPosted Date:

Oct 16 2024Although this role is advertised in Stevenage and Waltham, candidates based in other locations may be considered on a case by case basis.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.The Department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline (GSK) is recruiting for an associate director or director level quantitative clinical pharmacologist, with a robust background in Respiratory & Immunology.This position represents a key opportunity for professionals with PhD, MD, PharmD or equivalent doctoral background, who are experienced clinical pharmacologists and pharmacometricians to advance the vision and mission of GSK’s rapidly expanding Respiratory & Immunology portfolio.You will be expected to play a critical role in driving integration of end-to-end model-informed drug discovery and development. In addition, you will be accountable to define, coordinate and defend Clinical Pharmacology Modelling & Simulation development strategies for disease & therapeutics of interest at senior level meetings, and provide expert input into the clinical pharmacology evidence generation and integrated evidence plans. CPMS responsibilities and accountabilities generally commence at candidate selection with preparations of first time in human trials, and continue through to filing, registration, and market expansion.This is an chance to join a highly successful and well recognised team in the broader industry, reputed for their impact and publications success. The role brings together typically independent streams, combining modelling/simulation with clinical impact, touching the whole life cycle from first in human and beyond. It’s a hybrid role which succeeds by using modelling to accelerate and influence the success of a range of clinical development processes, contributing significantly to GSK’s mission.Key Responsibilities

Establish or guide mathematical model development to understand disease, its progression, and drug action to prevent, treat and cure diseases; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance.Define and execute a co-ordinated scientific and technical strategy (18-24 months planning horizon) with demonstrated ability to co-ordinate outputs from several expertise areas to determine strategy.Build and utilize mechanistic models of biological, physiological, and pathophysiological processes to evaluate a disease, its pathways and progression, as well as drug candidates or treatment modalities.Work in close collaboration with bench biologists, data scientists, computational biologists, clinicians and other partner line colleagues to inform research and development programs and improve our understanding of disease mechanisms.Develop and/or utilize state-of-the-art mathematical tools to gain insight into causal relationships between individual components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction.Create a collaboration framework with internal and external experts in the development and application of these models.Learn and apply emerging modeling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application.Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline.Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:PhD, MD, or PharmD with experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development.Significant experience in clinical pharmacology, modelling/simulation and drug development to solve practical problems in pharmaceutical industry.Significant experience in mechanistic mathematical modeling and the application of such to clinical questions in drug development.Experience in the respiratory therapy area.Preferred Qualifications:

If you have the following characteristics, it would be a plus:Additional experience in immunology would be of benefit.Demonstrated experience of collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.Evidenced experience making sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.Experience working with senior stakeholders in a cross functional environment.Strong track record of implementation of Model-Informed Drug Discovery and Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs.Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.Closing Date for Applications: 31 October 2024Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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