Director Quantitative Systems Pharmacology
Site Name: UK - Hertfordshire - Stevenage, USA - Massachusetts - Cambridge
Posted Date: Dec 2 2024
The Department of Clinical Pharmacology Modelling and Simulation (CPMS) at GSK is recruiting for a Director level Quantitative Systems Pharmacologist, with a robust background in either Respiratory & Immunology or Infections Diseases or Vaccines. This position represents an excellent opportunity for professionals with a PhD, MD, PharmD or equivalent doctoral background, who are experienced mathematical modellers, where one will use Quantitative Systems Pharmacology, mathematical modelling, and computational skills together with Pharmacometrics to advance the vision and mission of GSK's rapidly expanding portfolio.
Sought after experiences for this position include building and integrating mechanistic mathematical models and disease platforms with advanced analytical techniques (such as machine learning) to enhance the robustness and quality of decision-making from exploratory research, clinical development, registration, and life cycle management.
At GSK we develop therapies of various modalities for a broad range of indications. CPMS responsibilities and accountabilities commence at candidate selection stage with preparations of first time in human trials, and continue through to filing, registration, and market expansion. As a member of a global department with diverse expertise, you will enjoy a highly supportive environment for scientific innovation, business impact and professional growth. CPMS work directly supports GSK mission to help our patients feel better and live longer by getting ahead of disease together.
Key Responsibilities:
* Build, develop, guide development and/or 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; conduct simulations to generate virtual patients to optimize trial design; conduct meta-analyses as appropriate to generate knowledge through data re-use.
* 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.
* Contribute to clinical program design and dosing regimen selection, trial protocols, analysis plans, study reports and regulatory submissions as appropriate.
* Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians, statisticians and other partner line colleagues to inform research and development programs and improve our understanding of disease mechanisms.
* Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline.
* Present strategy and defend outcome of model-based approaches to internal governance boards and regulatory agencies.
* Promote Model-Informed Drug Discovery and Development (MID3) through external presentations at international conferences and publications in peer-reviewed scientific journals.
Basic Qualifications:
* PhD, MD, or PharmD with experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development.
* Substantial experience in utilizing mechanistic mathematical modelling and simulation (QSP, PKPD, etc.) to apply to questions in drug discovery and development to solve practical problems in industry and/or academia.
* Experience working with key stakeholders in a cross functional environment.
* Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.
* Passion for Quantitative Clinical Pharmacology and desire to innovate for better outcome.
* Strong track record of implementation of MIDD approaches to accelerate patient access to novel therapies.
* Strong publication record in peer-reviewed journals.
* Prior experience in clinical QSP modelling (especially, either in Respiratory & Immunology or Infections Diseases or Vaccines) in an industry setting.
Preferred Qualifications:
* A doctorate and a postdoc that are relevant to Quantitative Systems Pharmacology (e.g., Mathematics, Engineering, Physics, Systems Biology, Mathematical Modelling, etc.) is preferred but not required.
* Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
* Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.
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