Associate Director, Clinical Pharmacology Expert
2 days ago
GSK is a global biopharma company with a mission to unite science, technology, and talent to get ahead of disease together. We are seeking a highly motivated and experienced quantitative clinical pharmacology expert to join our team as an Associate Director, Clinical Pharmacology Expert.
About the RoleThis is an exciting opportunity to work on small molecules, biologics, and antibody drug conjugates in the Oncology therapeutic area. As a quantitative clinical pharmacology expert, you will be responsible for planning, conducting, and reporting drug-disease modelling, exposure-response analysis, simulation-based trial design, and dose selection, as well as population clinical pharmacology modelling.
Key Responsibilities- Develop and implement innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis, and quantitative systems pharmacology to enhance data use and trial efficiency.
- Present strategy and defend the outcome of model-based approaches to internal governance boards and regulatory agencies.
- Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions.
- Write or review clinical pharmacology components of regulatory documents and responses to ensure GSK products are rapidly and efficiently approved with optimum labelling.
- Implement best practices, trends, and lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline.
- Interact with line and middle management, staff, and external contacts on a functional, strategic, and tactical level.
- Promote model-informed drug discovery and development through external collaboration, journal publication, and conference presentation.
- A doctorate (PharmD, PhD, MD) in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering, or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia.
- 2+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling, and verifiable proficiency in pharmacometric tools NONMEM, Monolix, R, or SAS.
- 2+ years of experience in the design, analysis, interpretation, and reporting of Clinical Pharmacology studies per industry and regulatory standards.
- Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression, and treatments of cancers.
- Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.
- Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.
- Passion for quantitative clinical pharmacology and desire to innovate for better outcome.
- Prior experience in Oncology Research and Development is a plus.
- Experience working with senior stakeholders in a cross-functional environment.
- 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.
Why GSK?
GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. 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.
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