Director of Clinical Pharmacology Modeling and Simulation

Job description

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Director of Clinical Pharmacology Modeling and Simulation We have an exciting opportunity at GSK for a hands-on Quantitative Clinical Pharmacologist to join our team supporting infectious disease clinical development and lifecycle management programmes. GSK provides a supportive environment for scientists to learn, contribute and influence important development decisions through innovation, technical expertise and collaboration. You will be part of a science-driven group delivering clinical pharmacology and modelling & simulation excellence across research and development programmes. This is a senior individual contributor role with no formal line-management responsibility. You will act as the Clinical Pharmacology, Modeling and Simulation lead for assigned assets, combining hands-on pharmacometrics with strategic leadership. Your initial focus will include an important oral antibiotic lifecycle programme, with opportunities to support a broader portfolio of bacterial and viral assets. Responsibilities may span early clinical planning, late-stage development, registration and lifecycle management. This senior role is based in the United States. It is hybrid, combining regular on-site collaboration with remote work flexibility. You will need to be available for on-site meetings as required. For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following. Act as the Clinical Pharmacology, Modeling and Simulation representative on cross-functional medical development teams, shaping strategy for assigned infectious disease assets. Apply clinical pharmacokinetic, pharmacodynamic and modelling & simulation principles to support efficient clinical development, risk management, registration and lifecycle management. Play a central role in selecting and justifying doses and dosing regimens, including characterising exposure-response relationships and recommendations for relevant patient populations. Develop and apply population PK, PK/PD and exposure-response models, and conduct simulations to inform clinical trial design and development decisions. Present clinical pharmacology strategy and model-based evidence to governance boards, development teams and regulatory agencies. Apply relevant regulatory guidance to clinical pharmacology plans, study designs, analyses and development strategies. Advance model-informed drug development through high-quality scientific collaboration, external engagement, publication and conference presentation where appropriate. Design and interpret clinical pharmacology studies evaluating intrinsic and extrinsic factors affecting pharmacokinetics and pharmacodynamics. Identify appropriate opportunities to apply PBPK and other in silico approaches to evaluate drug interactions and special populations. Author and contribute to clinical development and regulatory documents, including protocols, reports, investigator brochures, briefing books, clinical pharmacology summaries and submission packages. Contribute clinical pharmacology evidence throughout regulatory interactions, from development-stage meetings through registration and product labelling. Learn and apply emerging modelling and simulation methodologies to improve programme efficiency and the quality of investment and development decisions. Collaborate effectively with clinicians, statisticians, biologists, regulatory colleagues, drug metabolism scientists and other matrix partners. Remain hands-on with quantitative analyses while providing strategic scientific leadership and clear recommendations to stakeholders. Why you? Basic Qualifications & Skills We are looking for professionals with these required skills to achieve our goals: Advanced degree in a relevant life science discipline, such as a PhD, PharmD or MD, supporting a successful career in quantitative clinical pharmacology within pharmaceutical research and development. Substantial experience in human clinical pharmacology, clinical pharmacokinetics, modelling & simulation and model-informed drug development, including the design, analysis and reporting of clinical studies. Demonstrated hands-on experience applying population PK, PK/PD or exposure-response models to clinical development questions. Practical experience with common quantitative clinical pharmacology tools, including NONMEM or Monolix and R. Experience using quantitative evidence to influence dose selection, clinical development plans and cross-functional programme decisions. Experience contributing to regulatory interactions or submission documents and applying relevant regulatory guidance to clinical development plans and studies. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Demonstrated expertise in pharmacometrics and modelling & simulation; experience in vaccines, infectious diseases or anti-infectives would be beneficial but is not essential. Knowledge of, or the ability to quickly learn, the mechanisms, endpoints, progression and treatment of diseases within infectious disease and other relevant therapy areas. Experience supporting late-stage clinical development, registration, lifecycle management, regulatory briefing books, dossiers or clinical pharmacology product labelling. Additional experience with Python, WinNonlin, Simcyp, SAS, MATLAB, PBPK or translational PK/PD approaches, alongside substantial human clinical development experience. Ability to communicate complex quantitative evidence clearly and succinctly, build effective collaborations and take personal accountability for delivery. Curiosity about emerging methodologies and technology, including high-performance computing and AI-enabled tools, with a willingness to learn and apply new approaches. Closing Date for Applications – 27th September #LI-GSK Please 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. At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Skills Animal Models, Artificia