Director, Clinical Pharmacology Modelling and Simulation (CPMS) Oncology

Business IntroductionAt 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&DPosition Summary 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 antibody drug conjugates, biologics and small molecules in the Oncology therapeutic area. CPMS responsibilities generally start post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. Working arrangement This role is hybrid. You will typically be expected on-site 2 to 3 days per week, with flexibility according to business needs and local policy. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 1. Defining and executing model-based development strategies for oncology projects 2. Planning, conducting and reporting of population PK and exposure-response analyses, simulation-based trial design and dose selection 3. Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies 4. Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions 5. Writing or reviewing 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) 6. Interacting with line and middle management, staff and external contacts on a functional, strategic and tactical level 7. 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 8. Implementing best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline 9. Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation Why You?Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals: 1. PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modeling/simulation to solve practical problems in industry or academi . PharmD or Master's degree in the same disciplines with an additional 3 years of relevant experience may be considered. 2. 5+ years of utilizing and leveraging population PK and exposure-response modelling in drug development; and verifiable proficiency in pharmacometric tools NONMEM or R. 3. 3+ years of experience in planning, performing, and reporting model-based analysis of clinical data per industry and regulatory standards. Preferred QualificationIf you have the following characteristics, it would be a plus: 1. Oncology drug development experience 2. Knowledge of or ability to quickly learn disease biology, mechanisms, trial design, endpoints and treatment paradigms in oncology 3. Solid experience with advanced pharmacometric approaches such as mechanistic PKPD modelling, longitudinal disease modeling, model-based meta-analysis, or adaptive dosing simulations 4. Ability to keep up-to-date with and propose the implementation of new modeling approaches to inform drug development 5. Experience with AI/ML tools and applications in pharmacometrics 6. Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results 7. Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks 8. Experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards 9. Passion for quantitative clinical pharmacology and desire to innovate for better outcome 10. Experience working with senior stakeholders in a cross functional environment 11. Excellent interpersonal skills with strong oral/written communication and presentation skills 12. 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 #GSK-LI Skills Antibody Drug Conjugates (ADC), Biologics, Biomarker Research, Biomarkers, Clinical Oncology, Clinical Pharmacology, Clinical Trial Designs, Data Science, Interpersonal Communication, Machine Learning (ML), Modeling Software, NONMEM, Oncology, Oncology Research, Oncology Trials, Pharmacology, Pharmacology Research, Pharmacometrics, PKPD Modeling, Quantitative Analysis, Quantitative Models, Regulatory Interactions, R Programming, Simulation Modeling, Simulation Programming* If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $188,100 to $313,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits inclu