Director, Quantitative Systems Pharmacology
PharmaBiotechPharmacovigilanceRegulatory AffairsQuality Assurancepharmacovigilanceemacroinformaws
Job description
Business Introduction 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 Director, Quantitative Systems Pharmacology 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. The Department of Clinical Pharmacology and Quantitative Medicine (CPQM) in the GSK Respiratory, Immunology and Inflammation Research Unit is recruiting for a Quantitative Systems Pharmacologist Lead. At GSK, CPQM is a newly established organization with the remit to become a Centre of Excellence in Model-Informed Drug Development (MIDD). It uniquely integrates clinical pharmacology, digital medicine, translational imaging, and mechanistic & systems modeling. The convergence of science and technology is changing discovery and development at GSK, allowing us to make advances on behalf of patients that were once thought impossible. Our R&D organization is delivering more innovation, better and faster, using new data and platform technologies that speed up discovery and development and improve the chance of success. This position represents a key opportunity for professionals with PhD, MD, or PharmD, who are experienced mechanistic modelers with experience in QSP and/or QST modeling, clinical pharmacology and pharmacometrics, to join the Quantitative Systems Pharmacology team to advance the vision and mission of GSK’s rapidly expanding Respiratory, Inflammation and Immunology Disease portfolio. Sought after experiences for this position include building mechanistic mathematical models and leveraging knowledge in the areas of scientific ML, inverse problems, AIML and/or statistical methodologies, to enhance the robustness and quality of model development to leverage for decision-making from exploratory research through clinical development. You will be expected to play a critical role in the day-to-day driving integration of end-to-end model-informed drug discovery and development through building and applying mechanistic QSP and QST models. In addition, you will be defining, implementing and coordinating QSP and QST related Clinical Pharmacology and Quantitative Medicine development strategies for disease and therapeutics of interest, and providing expert input into the clinical pharmacology evidence generation and integrated evidence plans in the Disease therapeutic area. This is an exciting opportunity to bring your vision and leadership to a new era of digital innovation in clinical pharmacology and quantitative medicine, profoundly impacting patient outcomes and shaping the future of R&D at GSK. Main responsibilities and accountabilities also include: · Build and/or guide mathematical model development to understand disease, its progression, and drug action to prevent, treat and cure diseases; conduct simulations to assess trial design performance · Apply mechanistic models of biological, physiological, and pathophysiological processes to evaluate a disease, its pathways and progression, as well as drug candidates or treatment modalities · Develop and/or utilize state-of-the-art mathematical tools including knowledge of inverse-problem modelling and simulation, scientific ML and/or statistical techniques to gain insight into causal relationships between individual components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction · Define and execute a coordinated scientific and technical strategy (3-24 months planning horizon) with demonstrated ability to co-ordinate outputs from several expertise areas to determine strategy · Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians, statisticians, AIML, imaging, biomarker and other partner line colleagues to inform research and development programs and improve our understanding of disease mechanisms · Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline · 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 · Able to efficiently and effectively interact with line and middle management, staff and external contacts on a functional, strategic and tactical level · Represent QSP CPQM on various internal advisory boards, companywide initiatives and/or leadership teams · Promote transparency and communicate R&D achievements through publications in appropriate scientific journals Why you? Basic Qualifications: · PhD, MD, or PharmD with experience in mechanistic modelling and simulation and systems biology with applications in pharmaceutical research and development · Minimum 7 years of experience in mechanistic mathematical modeling, inverse problem modeling and simulation, and/or scientific machine learning methodologies to be applied to pre-clinical and/or clinical questions in drug development to solve practical problems in the pharmaceutical industry · Experience working with senior stakeholders in a cross functional environment · 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 Preferred Qualifications: · Strong drive and agility to quickly learn and build knowledge on a drug-disease system, the mechanism, endpoints, progression, prevention, treatments, and trial design · Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results · Clear evidence / experience in making sound judgement in complex situations and adapting to changing business needs by prioritizing multiple tasks · Prior experience in Hepatology, Respiratory and/or Cardiometabolic diseases is a plus “ Candidates at an Associate Director-level (or lower) may be considered for other roles " LI-GSK* Skills Drug Design, Drug Development, Drug Discovery Process, Drug Discovery Research, Medication Safety, Molecular Modeling, Pharmaceutical Regulatory Compliance, Ph
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